Breast ReconstructionNCT05028101
The Impact of Functional Medicine On Wound Healing From Delayed Autologous Breast Reconstruction
A study testing Delayed autologous breast reconstruction and Perioperative Functional Medicine (FM) Care in people with Breast Reconstruction, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study will examine if a functional medicine approach, delivered as an adjunct to standard of care, is feasible, safe, clinically beneficial and cost-effective for patients undergoing autologous breast reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- Delayed autologous breast reconstruction and Perioperative Functional Medicine (FM) Care
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2023to 6 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing uni- or bilateral delayed abdominally-based breast reconstruction at the Cleveland Clinic.
- Women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study.
- Capable of providing written informed consent prior to any protocol-specified procedures.
- Willing to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- BMI > 37
- Women who are pregnant, nursing, or planning pregnancy during the trial.
- Have a serious concomitant illness that could interfere with the subject's participation in the trial (allergy preventing supplement usage)
- Undergoing chemotherapy during proposed nutritional intervention (3 months before or after surgery).
- Are unable to or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access.
- Clinical diagnosis of cognitive impairment or dementia.
- Known sensitivity to nutritional supplements.
- History of being seen or had intervention/care in Functional Medicine or following Functional Medicine principles.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Functional Medicine On Wound Healing From Delayed Autologous Breast Reconstruction - A Feasibility Study
This study will examine if a functional medicine approach, delivered as an adjunct to standard of care, is feasible, safe, clinically beneficial and cost-effective for patients undergoing autologous breast reconstruction.
Read the detailed description
Autologous microsurgical breast reconstruction is associated with a protracted recovery and a significant amount of opioid utilization. Many institutions have "Enhanced Recovery After Surgery (ERAS)" protocols that utilize multi-modality therapy to decrease opioid use, length of stay, hospital costs and expedite recovery. However, nutrition-based interventions used perioperatively are not currently part of ERAS protocols for surgical sub-specialties, including breast surgery despite ample literature that nutrition (with or without supplements) can improve surgical wound healing and other outcomes.
The functional medicine model of care expands upon the conventional medicine model of care by providing a unique operating system that works to reverse illness, promote health and optimize function. A foundation of functional medicine is the use of food as medicine to prevent, treat and reverse chronic disease. Dietary supplements are used as an adjunct to nutrition-based interventions. Dietitians support patients with implementing food plans, and health coaches support patients through lifestyle and behavioral changes focused on sleep, exercise and movement and stress reduction.
This study will examine the feasibility of implementing a functional medicine-based intervention focused on nutrition and lifestyle, and the ability of the intervention to improve wound healing and decrease various post-operative complications in patients undergoing autologous breast reconstruction.
All participants will be asked to attend study visits, complete questionnaires and have their blood drawn. Participants randomized to standard of care plus functional medicine will be asked to also follow a specific food plan, take specific dietary supplements, exercise and engage in stress reduction techniques for 3 months prior to and after surgery. The study duration is 6 months.
- Conditions
- Breast Reconstruction
- Being tested
- Delayed autologous breast reconstruction, Perioperative Functional Medicine (FM) Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed autologous breast reconstructionProcedure or surgery
SOC: Delayed autologous breast reconstruction
Perioperative Functional Medicine (FM) CareBehavioural
SOC plus FM: A food plan that encourages consumption of nutrient-dense whole foods. It provides adequate protein, balanced quality fats and foods which contain targeted nutrients essential to proper wound healing. Select dietary supplements will be provided as an adjunct to the food plan. Health coaching will support optimal sleep, adequate movement/exercise and stress reduction.
| Study group | Role | What they receive |
|---|---|---|
| Control (Standard of Care (SOC)) | Active comparator | Reconstructive surgical technique, delayed autologous breast reconstruction, and usual local anesthesia and analgesia during hospital stay. Receives: Procedure: Delayed autologous breast reconstruction |
| SOC + Functional Medicine | Experimental | Reconstructive surgical technique, delayed autologous breast reconstruction, and usual local anesthesia and analgesia during hospital stay.
Perioperative nutrition and lifestyle-based interventions along with select dietary supplements. Receives: Procedure: Delayed autologous breast reconstruction; Behavioral: Perioperative Functional Medicine (FM) Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility defined by percent randomized.
Success will be defined as enrolling and randomizing 25% or more of those screened per arm.
Measured: Baseline
Number of in-person visits completed.
Number of in-person visits completed.
Measured: Up to 26 weeks
Number of virtual visits completed.
Number of virtual visits completed.
Measured: Up to 26 weeks
Adherence to recommended dietary intervention.
Percent of participants adhering to recommended dietary intervention.
Measured: Up to 26 weeks
Adherence to recommended lifestyle interventions.
Percent of participants adhering to lifestyle interventions.
Measured: Up to 26 weeks
Adherence to prescribed dietary supplementation.
Percent of participants adhering to prescribed dietary supplementation.
Measured: Up to 26 weeks
Percent completion of study-specific surveys.
Percent of the following surveys completed:
- BreastQ (baseline, wks 12, and 26)
- PROMIS Questionnaire (baseline and wks 5, 12 and 26)
- Medical Symptom Questionnaire (MSQ) (baseline and wks 5, 12 and 26)
- Nutrition and Lifestyle Adherence Survey (randomization and then weekly for the duration of the study)
- Dietary Supplementation Adherence Survey (only those randomized to SOC plus functional medicine; wk1 and then weekly for the duration of the study)
Note: the BRA and SKIN surveys are not completed by the patient, but by the provider.
Measured: Up to 26 weeks
Number of Serious Adverse Events (SAE's).
Number of Serious Adverse Events (SAE's).
Measured: Up to 26 weeks
Secondary outcomes (71)
Number of re-operations for wound management.
Number of re-operations for wound management (mean \& standard deviation).
Measured: Up to 26 weeks
Number of hospital re-admissions.
Number of hospital re-admissions (mean \& standard deviation).
Measured: Up to 26 weeks
Length-of-stay upon hospital re-admission.
Length-of-stay upon hospital re-admission (mean \& standard deviation).
Measured: Up to 26 weeks
Number of antibiotic prescriptions.
Infection rates assessed by number of antibiotic prescriptions (mean \& standard deviation). Standard of care (SOC), post-surgery prophylactic antibiotic prescriptions will not be considered.
Measured: Up to 26 weeks
Correlate all post-operative complications with the predicted risk from the BRA scoring system.
Surgical complications will be measured within each arm and the predicted risk will be compared to the actual incidence. Surgical complications is defined as the total number of all the complications (eg. surgical site infection, seroma, dehiscence, flap loss and reoperation). The minimum and maximum probabilities of experiencing surgical complications based on the BRA scoring system are 11.7% and 57.9%, respectively. The American Society of Plastic Surgeons Tracking Operations and Outcomes for Plastic Surgeons (TOPS) database which tracks 30-day outcomes for plastic surgery was used to determine the minimum and maximum probabilities of this complication.
Measured: Up to 26 weeks
Correlate post-operative surgical site infection complications with the predicted risk from the BRA scoring system.
Surgical site infection (SSI) will be measured within each arm and the predicted risk will be compared to the actual incidence. SSI is defined as a superficial SSI or deep incisional SSI.
The minimum and maximum probabilities of experiencing a SSI based on the BRA scoring system are 2.7% and 54.8%, respectively. The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database which tracks 30-day outcomes for plastic surgery was used to determine the minimum and maximum probabilities of this complication.
Measured: Up to 26 weeks
Correlate post-operative seroma complications with the predicted risk from the BRA scoring system.
Seroma will be measured within each arm and the predicted risk will be compared to the actual incidence. Seroma is defined as a fluid collection that develops after surgery necessitating aspiration or surgical intervention. The minimum and maximum probabilities of experiencing a seroma based on the BRA scoring system are 1.8% and 13.8%, respectively. The American Society of Plastic Surgeons Tracking Operations and Outcomes for Plastic Surgeons (TOPS) database which tracks 30-day outcomes for plastic surgery was used to determine the minimum and maximum probabilities of this complication.
Measured: Up to 26 weeks
Correlate post-operative dehiscence complications with the predicted risk from the BRA scoring system.
Dehiscence will be measured within each arm and the predicted risk will be compared to the actual incidence. Dehiscence is defined as separation of the layers of a surgical wound, which may be partial or complete with disruption of the fascia. The minimum and maximum probabilities of experiencing dehiscence based on the BRA scoring system are 3.7% and 50.2%, respectively. The American Society of Plastic Surgeons Tracking Operations and Outcomes for Plastic Surgeons (TOPS) database which tracks 30-day outcomes for plastic surgery was used to determine the minimum and maximum probabilities of this complication.
Measured: Up to 26 weeks
Correlate post-operative flap loss complications with the predicted risk from the BRA scoring system.
Flap loss will be measured within each arm and the predicted risk will be compared to the actual incidence. Flap loss is defined as complete removal of flap after complication. The minimum and maximum probabilities of experiencing flap loss based on the BRA scoring system are 4.3% and 49.6%, respectively. The American Society of Plastic Surgeons Tracking Operations and Outcomes for Plastic Surgeons (TOPS) database which tracks 30-day outcomes for plastic surgery was used to determine the minimum and maximum probabilities of this complication.
Measured: Up to 26 weeks
Correlate post-operative reoperation complications with the predicted risk from the BRA scoring system.
Reoperation will be measured within each arm and the predicted risk will be compared to the actual incidence. Reoperation is defined as a return to operating room for a procedure. This does not refer to procedures performed in the office under local. The minimum and maximum probabilities of experiencing reoperation based on the BRA scoring system are 4.3% and 23.0%, respectively. The American Society of Plastic Surgeons Tracking Operations and Outcomes for Plastic Surgeons (TOPS) database which tracks 30-day outcomes for plastic surgery was used to determine the minimum and maximum probabilities of this complication.
Measured: Up to 26 weeks
Evaluate narcotic utilization while in the hospital.
Morphine utilization (Oral morphine equivalents (mg)).
Measured: While in hospital, an average of 3 days
Evaluate narcotic utilization while in the hospital.
Morphine utilization (Oral morphine equivalents (mg/kg)).
Measured: While in hospital, an average of 3 days
Evaluate narcotic utilization while in the hospital.
Morphine utilization (Oral morphine equivalents (mg/kg/day)).
Measured: While in hospital, an average of 3 days
Evaluate narcotic utilization while in the hospital.
Morphine utilization (IV morphine equivalents (mg)).
Measured: While in hospital, an average of 3 days
Evaluate narcotic utilization while in the hospital.
Morphine utilization (IV morphine equivalents (mg/kg)).
Measured: While in hospital, an average of 3 days
Evaluate narcotic utilization while in the hospital.
Morphine utilization (IV morphine equivalents (mg/kg/day).
Measured: While in hospital, an average of 3 days
Evaluate narcotic utilization while in the hospital.
Morphine utilization (total morphine equivalents (mg) while in hospital.
Measured: While in hospital, an average of 3 days
Evaluate narcotic utilization while in the hospital.
Morphine utilization (total morphine equivalents (mg/kg) while in hospital.
Measured: While in hospital, an average of 3 days
Evaluate narcotic utilization while in the hospital.
Morphine utilization (total morphine equivalents (mg/kg/day) while in hospital.
Measured: While in hospital, an average of 3 days
Change in Complete Blood Count with Differential (CBC).
Change in CBC (mean \& standard deviation).
Measured: Baseline to 12 weeks
Change in Complete Blood Count with Differential (CBC).
Change in CBC (mean \& standard deviation).
Measured: Baseline to 26 weeks
Change in Comprehensive Metabolic Pane (CMP).
Change in CMP (mean \& standard deviation).
Measured: Baseline to 12 weeks
Change in Comprehensive Metabolic Pane (CMP).
Change in CMP (mean \& standard deviation).
Measured: Baseline to 26 weeks
Change in Hemoglobin A1c (HbA1c).
Change in % HbA1c (mean \& standard deviation).
Measured: Baseline to 12 weeks
Change in Hemoglobin A1c (HbA1c).
Change in % HbA1c (mean \& standard deviation).
Measured: Baseline to 26 weeks
Change in nuclear magnetic resonance (NMR) LipoProfile.
Change in NMR LipoProfile (mean \& standard deviation).
LDL Particle Number (L): (Normal Range: < 1000 nmol) LDL Cholesterol (dL): (Normal Range: 0 - 99 mg) HDL Cholesterol (dL) : (Normal Range: >39 mg) Triglycerides (dL): (Normal Range: 0 - 149 mg) Total Cholesterol (dL): (Normal Range: 100 - 199 mg) Total HDL Particles (L): (Normal Range: >=30.5 umol) Small LDL-P (L): (Normal Range: < =527 nmol) Large VLDL-P (L): (Normal Range: < =2.7 nmol/L) Large HDL-P (L): (Normal Range: >=4.8 umol) VLDL Size (nm): (Normal Range: < =46.6 nm) LDL Size (nm): (Normal Range: >20.5 nm) HDL Size (nm): (Normal Range: >=9.2 nm) LP/IR Score: (Normal Range: < =45)
Measured: Baseline to 12 weeks
Change in NMR LipoProfile.
Change in NMR LipoProfile (mean \& standard deviation).
LDL Particle Number (L): (Normal Range: < 1000 nmol) LDL Cholesterol (dL): (Normal Range: 0 - 99 mg) HDL Cholesterol (dL) : (Normal Range: >39 mg) Triglycerides (dL): (Normal Range: 0 - 149 mg) Total Cholesterol (dL): (Normal Range: 100 - 199 mg) Total HDL Particles (L): (Normal Range: >=30.5 umol) Small LDL-P (L): (Normal Range: < =527 nmol) Large VLDL-P (L): (Normal Range: < =2.7 nmol/L) Large HDL-P (L): (Normal Range: >=4.8 umol) VLDL Size (nm): (Normal Range: < =46.6 nm) LDL Size (nm): (Normal Range: >20.5 nm) HDL Size (nm): (Normal Range: >=9.2 nm) LP/IR Score: (Normal Range: < =45)
Measured: Baseline to 26 weeks
Change in high-sensitivity C-Reactive Protein (hsCRP).
Change in hsCRP (mean \& standard deviation).
Measured: Baseline to 12 weeks
Change in high-sensitivity C-Reactive Protein (hsCRP).
Change in hsCRP (mean \& standard deviation).
Measured: Baseline to 26 weeks
Change in Vitamin D.
Change in Vitamin D (ng/mL) (mean \& standard deviation).
Measured: Baseline to 12 weeks
Change in Vitamin D.
Change in Vitamin D (ng/mL) (mean \& standard deviation).
Measured: Baseline to 26 weeks
Change in OmegaCheck.
Change in OmegaCheck (mean \& standard deviation).
Arachidonic Acid (% by wt) Arachidonic Acid/EPA ratio Docosahexaenoic acid (DHA) (% by wt) Docosapentaenoic acid (DPA) (% by wt) Eicosapentaenoic acid (EPA) (% by wt) Linoleic Acid (% by wt) Omega-3 total (% by wt) Omega-6 total (% by wt) Omega-6/3 Ratio OmegaCheck (total EPA+DPA+DHA reported as % by wt)
Measured: Baseline to 12 weeks
Change in OmegaCheck.
Change in OmegaCheck (mean \& standard deviation).
Arachidonic Acid (% by wt) Arachidonic Acid/EPA ratio Docosahexaenoic acid (DHA) (% by wt) Docosapentaenoic acid (DPA) (% by wt) Eicosapentaenoic acid (EPA) (% by wt) Linoleic Acid (% by wt) Omega-3 total (% by wt) Omega-6 total (% by wt) Omega-6/3 Ratio OmegaCheck (total EPA+DPA+DHA reported as % by wt)
Measured: Baseline to 26 weeks
Total healthcare costs.
Measure cost of laboratory testing, dietary supplementation, initial hospital length of stay, and post-surgical complications requiring intervention (if applicable).
Measured: At 26 weeks
Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
Change in PROMIS GPH scores (mean \& standard deviation).
PROMIS is an NIH-validated set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children within the general population and in those living with chronic conditions. This is considered SOC for the Center for Functional Medicine. Scores are transformed into T-Scores. The mean (SD) of the US General Population is 50 (10). Higher scores mean better outcomes
Measured: Baseline to week 12
Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
Change in PROMIS GPH scores (mean \& standard deviation).
PROMIS is an NIH-validated set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children within the general population and in those living with chronic conditions. This is considered SOC for the Center for Functional Medicine. Scores are transformed into T-Scores. The mean (SD) of the US General Population is 50 (10). Higher scores mean better outcomes
Measured: Baseline to week 26
Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
Change in PROMIS GPH scores (mean \& standard deviation).
PROMIS is an NIH-validated set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children within the general population and in those living with chronic conditions. This is considered SOC for the Center for Functional Medicine. Scores are transformed into T-Scores. The mean (SD) of the US General Population is 50 (10). Higher scores mean better outcomes.
Measured: Baseline to week 5
Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
Clinically-meaningful change in PROMIS GPH, or improvements in 5.00 points or more (mean \& standard deviation).
PROMIS is an NIH-validated set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children within the general population and in those living with chronic conditions. This is considered SOC for the Center for Functional Medicine. Scores are transformed into T-Scores. The mean (SD) of the US General Population is 50 (10). Higher scores mean better outcomes.
Improvement: ≥5.00 points Slightly Better: 2.50 to 4.99 points Similar: -2.49 to 2.49 points Slightly Worse: -2.50 to -4.99 points
Measured: Baseline to week 5
Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
Clinically-meaningful change in PROMIS GPH, or improvements in 5.00 points or more (mean \& standard deviation).
PROMIS is an NIH-validated set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children within the general population and in those living with chronic conditions. This is considered SOC for the Center for Functional Medicine. Scores are transformed into T-Scores. The mean (SD) of the US General Population is 50 (10). Higher scores mean better outcomes.
Improvement: ≥5.00 points Slightly Better: 2.50 to 4.99 points Similar: -2.49 to 2.49 points Slightly Worse: -2.50 to -4.99 points
Measured: Baseline to week 12
Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
Clinically-meaningful change in PROMIS GPH, or improvements in 5.00 points or more (mean \& standard deviation).
PROMIS is an NIH-validated set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children within the general population and in those living with chronic conditions. This is considered SOC for the Center for Functional Medicine. Scores are transformed into T-Scores. The mean (SD) of the US General Population is 50 (10). Higher scores mean better outcomes.
Improvement: ≥5.00 points Slightly Better: 2.50 to 4.99 points Similar: -2.49 to 2.49 points Slightly Worse: -2.50 to -4.99 points
Measured: Baseline to week 26
Change in mean value of the continuous variable of PROMIS GPH.
Change in mean value of the continuous variable of PROMIS GPH.
Measured: Baseline to week 5
Change in mean value of the continuous variable of PROMIS GPH.
Change in mean value of the continuous variable of PROMIS GPH.
Measured: Baseline to week 12
Change in mean value of the continuous variable of PROMIS GPH.
Change in mean value of the continuous variable of PROMIS GPH.
Measured: Baseline to week 26
Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Mental Health (GMH).
Change in PROMIS GMH scores (mean \& standard deviation).
PROMIS is an NIH-validated set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children within the general population and in those living with chronic conditions. This is considered SOC for the Center for Functional Medicine. Scores are transformed into T-Scores. The mean (SD) of the US General Population is 50 (10). Higher scores mean better outcomes.
Measured: Baseline to week 5
Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Mental Health (GMH).
Change in PROMIS GMH scores (mean \& standard deviation).
PROMIS is an NIH-validated set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children within the general population and in those living with chronic conditions. This is considered SOC for the Center for Functional Medicine. Scores are transformed into T-Scores. The mean (SD) of the US General Population is 50 (10). Higher scores mean better outcomes.
Measured: Baseline to week 12
Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Mental Health (GMH).
Change in PROMIS GMH scores (mean \& standard deviation).
PROMIS is an NIH-validated set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children within the general population and in those living with chronic conditions. This is considered SOC for the Center for Functional Medicine. Scores are transformed into T-Scores. The mean (SD) of the US General Population is 50 (10). Higher scores mean better outcomes.
Measured: Baseline to week 26
Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Mental Health (GMH) scores.
Clinically-meaningful change in PROMIS GMH, or improvements in 5.00 points or more (mean \& standard deviation).
PROMIS is an NIH-validated set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children within the general population and in those living with chronic conditions. This is considered SOC for the Center for Functional Medicine. Scores are transformed into T-Scores. The mean (SD) of the US General Population is 50 (10). Higher scores mean better outcomes.
Improvement: ≥5.00 points Slightly Better: 2.50 to 4.99 points Similar: -2.49 to 2.49 points Slightly Worse: -2.50 to -4.99 points
Measured: Baseline to week 5
Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Mental Health (GMH) scores.
Clinically-meaningful change in PROMIS GMH, or improvements in 5.00 points or more (mean \& standard deviation).
PROMIS is an NIH-validated set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children within the general population and in those living with chronic conditions. This is considered SOC for the Center for Functional Medicine. Scores are transformed into T-Scores. The mean (SD) of the US General Population is 50 (10). Higher scores mean better outcomes.
Improvement: ≥5.00 points Slightly Better: 2.50 to 4.99 points Similar: -2.49 to 2.49 points Slightly Worse: -2.50 to -4.99 points
Measured: Baseline to week 12
Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Mental Health (GMH) scores.
Clinically-meaningful change in PROMIS GMH, or improvements in 5.00 points or more (mean \& standard deviation).
PROMIS is an NIH-validated set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children within the general population and in those living with chronic conditions. This is considered SOC for the Center for Functional Medicine. Scores are transformed into T-Scores. The mean (SD) of the US General Population is 50 (10). Higher scores mean better outcomes.
Improvement: ≥5.00 points Slightly Better: 2.50 to 4.99 points Similar: -2.49 to 2.49 points Slightly Worse: -2.50 to -4.99 points
Measured: Baseline to week 26
Change in mean value of the continuous variable of PROMIS GMH.
Change in mean value of the continuous variable of PROMIS GMH.
Measured: Baseline to week 5
Change in mean value of the continuous variable of PROMIS GMH.
Change in mean value of the continuous variable of PROMIS GMH.
Measured: Baseline to week 12
Change in mean value of the continuous variable of PROMIS GMH.
Change in mean value of the continuous variable of PROMIS GMH.
Measured: Baseline to week 26
Change in Breast-Q scores.
Change in Breast-Q score (mean \& standard deviation).
Breast-Q is a validated comprehensive evaluation of breast health and wellness. Transformed scores range from 0-100 with higher score means greater satisfaction or better QoL.
Measured: Baseline to week 12
Change in Breast-Q scores.
Change in Breast-Q score (mean \& standard deviation).
Breast-Q is a validated comprehensive evaluation of breast health and wellness. Transformed scores range from 0-100 with higher score means greater satisfaction or better QoL.
Measured: Baseline to week 26
Change in Medical System Questionnaire (MSQ) scores.
Change participant's global symptoms measured by change in MSQ scores (mean \& standard deviation).
The MSQ identifies symptoms that a patient has experienced over the previous 48 hours based upon their health profile. The MSQ utilizes a semantic differential scale to determine how often a patient is experiencing a specific symptom and to track a participant's progress. All scores are totaled and higher MSQ scores indicate worsening of symptoms while lower scores indicate symptom improvement. This is considered SOC for the Center for Functional Medicine.
Total Score Range: 0-352, with higher scores meaning worse outcomes.
Measured: Baseline to week 5
Change in Medical System Questionnaire (MSQ) scores.
Change participant's global symptoms measured by change in MSQ scores (mean \& standard deviation).
The MSQ identifies symptoms that a patient has experienced over the previous 48 hours based upon their health profile. The MSQ utilizes a semantic differential scale to determine how often a patient is experiencing a specific symptom and to track a participant's progress. All scores are totaled and higher MSQ scores indicate worsening of symptoms while lower scores indicate symptom improvement. This is considered SOC for the Center for Functional Medicine.
Total Score Range: 0-352, with higher scores meaning worse outcomes.
Measured: Baseline to week 12
Change in Medical System Questionnaire (MSQ) scores.
Change participant's global symptoms measured by change in MSQ scores (mean \& standard deviation).
The MSQ identifies symptoms that a patient has experienced over the previous 48 hours based upon their health profile. The MSQ utilizes a semantic differential scale to determine how often a patient is experiencing a specific symptom and to track a participant's progress. All scores are totaled and higher MSQ scores indicate worsening of symptoms while lower scores indicate symptom improvement. This is considered SOC for the Center for Functional Medicine.
Total Score Range: 0-352, with higher scores meaning worse outcomes.
Measured: Baseline to week 26
Change in Nutrition and Lifestyle Adherence Survey scores.
Nutrition and lifestyle changes as measured by changes in Nutrition and Lifestyle Adherence Survey scores, which assesses participant diet, exercise and stress management in the prior week.
Nutrition: Range of available points: 0-45 (higher = better) Sleep: Range of available points: 0-3 points (higher = better) Exercise/Movement: Range of available points: 0-20 points (higher = better) Stress Management: 0-8 points (higher = better) Total Composite Score Range: 0-76 (higher = better)
Measured: Baseline to week 12
Change in Nutrition and Lifestyle Adherence Survey scores.
Nutrition and lifestyle changes as measured by changes in Nutrition and Lifestyle Adherence Survey scores, which assesses participant diet, exercise and stress management in the prior week.
Nutrition: Range of available points: 0-45 (higher = better) Sleep: Range of available points: 0-3 points (higher = better) Exercise/Movement: Range of available points: 0-20 points (higher = better) Stress Management: 0-8 points (higher = better) Total Composite Score Range: 0-76 (higher = better)
Measured: Baseline to week 26
Change in Dietary Supplement Adherence Survey scores.
Dietary supplementation use as part of the study measured by change Dietary Supplement Adherence Survey scores.
O.N.E Omega: 0-4 points Probiotic 50B: 0-4 points Vitamin D3: 0-4 points Whey Basics: 0-4 points Curcumin with Bioperine: 0-4 points Zinc 30: 0-4 points Bromelain: 0-4 points
- Only taken 1 week prior to and after surgery Total Score Range: 0-24 (except for the 1 week prior to and after surgery when the total score range is: 0-28, higher = better)
Measured: Baseline to week 12
Change in Dietary Supplement Adherence Survey scores
Dietary supplementation use as part of the study measured by change Dietary Supplement Adherence Survey scores.
O.N.E Omega: 0-4 points Probiotic 50B: 0-4 points Vitamin D3: 0-4 points Whey Basics: 0-4 points Curcumin with Bioperine: 0-4 points Zinc 30: 0-4 points Bromelain: 0-4 points
- Only taken 1 week prior to and after surgery Total Score Range: 0-24 (except for the 1 week prior to and after surgery when the total score range is: 0-28 higher = better)
Measured: Baseline to week 26
Number of days wounds necessitate dressing changes or packing post-surgery.
Evaluation of wound healing by by assessing the number of days wounds necessitate dressing changes or packing post-surgery (mean \& standard deviation).
Measured: At 26 weeks
SKIN Survey composite scores.
The SKIN Survey composite score assesses severity and extent of mastectomy skin flap necrosis (MSFN) (eg. A1, B3, D2, etc.).
Depth of MSFN is assessed from A to D:
A = None, no evidence of MSFN B = Color change of skin flap suggesting impaired perfusion or ischemic injury (may be cyanosis or erythema) C = Partial thickness skin flap necrosis resulting in at least epidermal sloughing D = Full thickness skin flap necrosis
Surface area of MSFN (%) is assessed by providing a value from 1 to 4:
- - None 0%
- - Breast, change affects 1-10% of breast skin or NAC, change affects 1-10% of nipple-areolar complex
- - Breast, change affects 11-30 % of breast skin or NAC, 11-30% of NAC affected, or total nipple involvement
- - Change affects >30% of breast skin or 30% of NAC
Measured: At 14 weeks
SKIN Survey composite scores.
The SKIN Survey composite score assesses severity and extent of mastectomy skin flap necrosis (MSFN) (eg. A1, B3, D2, etc.).
Depth of MSFN is assessed from A to D:
A = None, no evidence of MSFN B = Color change of skin flap suggesting impaired perfusion or ischemic injury (may be cyanosis or erythema) C = Partial thickness skin flap necrosis resulting in at least epidermal sloughing D = Full thickness skin flap necrosis
Surface area of MSFN (%) is assessed by providing a value from 1 to 4:
- - None 0%
- - Breast, change affects 1-10% of breast skin or NAC, change affects 1-10% of nipple-areolar complex
- - Breast, change affects 11-30 % of breast skin or NAC, 11-30% of NAC affected, or total nipple involvement
- - Change affects >30% of breast skin or 30% of NAC
Measured: At 15 weeks
SKIN Survey composite scores.
The SKIN Survey composite score assesses severity and extent of mastectomy skin flap necrosis (MSFN) (eg. A1, B3, D2, etc.).
Depth of MSFN is assessed from A to D:
A = None, no evidence of MSFN B = Color change of skin flap suggesting impaired perfusion or ischemic injury (may be cyanosis or erythema) C = Partial thickness skin flap necrosis resulting in at least epidermal sloughing D = Full thickness skin flap necrosis
Surface area of MSFN (%) is assessed by providing a value from 1 to 4:
- - None 0%
- - Breast, change affects 1-10% of breast skin or NAC, change affects 1-10% of nipple-areolar complex
- - Breast, change affects 11-30 % of breast skin or NAC, 11-30% of NAC affected, or total nipple involvement
- - Change affects >30% of breast skin or 30% of NAC
Measured: At 17 weeks
Average incision length.
Wound healing as measured by average incision length (mean \& standard deviation).
Measured: At 14 weeks
Average incision length.
Wound healing as measured by average incision length (mean \& standard deviation).
Measured: At 15 weeks
Average incision length.
Wound healing as measured by average incision length (mean \& standard deviation).
Measured: At 17 weeks
Average dehiscence length.
Wound healing as measured by average dehiscence length (separation of the incision line) (mean \& standard deviation).
Measured: At 14 weeks
Average dehiscence length.
Wound healing as measured by average dehiscence (separation of the incision line) length (mean \& standard deviation).
Measured: At 15 weeks
Average dehiscence length.
Wound healing as measured by average dehiscence (separation of the incision line) length (mean \& standard deviation).
Measured: At 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start20 Feb 2023
- Primary completion6 Jun 2024
- Study completion6 Jun 2024
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda Shallcross, ND, MPH, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028101
- Sponsor's protocol ID
- CASE4119
- Status last verified
- Jun 2024
- First submitted
- 28 Jun 2021
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share Individual Participant Data (IPD)
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Functional Medicine On Wound Healing From Delayed Autologous Breast Reconstruction - A Feasibility Study
- ClinicalTrials.gov ID
- NCT05028101
- Acronym / sponsor ID
- CASE4119
- Conditions
- Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine if a functional medicine approach, delivered as an adjunct to standard of care, is feasible, safe, clinically beneficial and cost-effective for patients undergoing autologous breast reconstruction.
Detailed description
Autologous microsurgical breast reconstruction is associated with a protracted recovery and a significant amount of opioid utilization. Many institutions have "Enhanced Recovery After Surgery (ERAS)" protocols that utilize multi-modality therapy to decrease opioid use, length of stay, hospital costs and expedite recovery. However, nutrition-based interventions used perioperatively are not currently part of ERAS protocols for surgical sub-specialties, including breast surgery despite ample literature that nutrition (with or without supplements) can improve surgical wound healing and other outcomes.
The functional medicine model of care expands upon the conventional medicine model of care by providing a unique operating system that works to reverse illness, promote health and optimize function. A foundation of functional medicine is the use of food as medicine to prevent, treat and reverse chronic disease. Dietary supplements are used as an adjunct to nutrition-based interventions. Dietitians support patients with implementing food plans, and health coaches support patients through lifestyle and behavioral changes focused on sleep, exercise and movement and stress reduction.
This study will examine the feasibility of implementing a functional medicine-based intervention focused on nutrition and lifestyle, and the ability of the intervention to improve wound healing and decrease various post-operative complications in patients undergoing autologous breast reconstruction.
All participants will be asked to attend study visits, complete questionnaires and have their blood drawn. Participants randomized to standard of care plus functional medicine will be asked to also follow a specific food plan, take specific dietary supplements, exercise and engage in stress reduction techniques for 3 months prior to and after surgery. The study duration is 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (Standard of Care (SOC)) | Active comparator | Procedure: Delayed autologous breast reconstructionReconstructive surgical technique, delayed autologous breast reconstruction, and usual local anesthesia and analgesia during hospital stay. |
| SOC + Functional Medicine | Experimental | Procedure: Delayed autologous breast reconstruction, Behavioral: Perioperative Functional Medicine (FM) CareReconstructive surgical technique, delayed autologous breast reconstruction, and usual local anesthesia and analgesia during hospital stay. Perioperative nutrition and lifestyle-based interventions along with select dietary supplements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing uni- or bilateral delayed abdominally-based breast reconstruction at the Cleveland Clinic.
- Women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study.
- Capable of providing written informed consent prior to any protocol-specified procedures.
- Willing to adhere to the study visit schedule and other protocol requirements.
Key exclusion criteria (8 listed)
- BMI > 37
- Women who are pregnant, nursing, or planning pregnancy during the trial.
- Have a serious concomitant illness that could interfere with the subject's participation in the trial (allergy preventing supplement usage)
- Undergoing chemotherapy during proposed nutritional intervention (3 months before or after surgery).
- Are unable to or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delayed autologous breast reconstructionSOC: Delayed autologous breast reconstruction | Procedure or surgery | Control (Standard of Care (SOC)), SOC + Functional Medicine |
| Perioperative Functional Medicine (FM) CareSOC plus FM: A food plan that encourages consumption of nutrient-dense whole foods. It provides adequate protein, balanced quality fats and foods which contain targeted nutrients essential to proper wound healing. Select dietary supplements will be provided as an adjunct to the food plan. Health coaching will support optimal sleep, adequate movement/exercise and stress reduction. | Behavioural | SOC + Functional Medicine |
Primary outcome
Feasibility defined by percent randomized.
Time frame: Baseline
Success will be defined as enrolling and randomizing 25% or more of those screened per arm.
Number of in-person visits completed.
Time frame: Up to 26 weeks
Number of in-person visits completed.
Number of virtual visits completed.
Time frame: Up to 26 weeks
Number of virtual visits completed.
Adherence to recommended dietary intervention.
Time frame: Up to 26 weeks
Percent of participants adhering to recommended dietary intervention.
Adherence to recommended lifestyle interventions.
Time frame: Up to 26 weeks
Percent of participants adhering to lifestyle interventions.
Adherence to prescribed dietary supplementation.
Time frame: Up to 26 weeks
Percent of participants adhering to prescribed dietary supplementation.
Percent completion of study-specific surveys.
Time frame: Up to 26 weeks
Percent of the following surveys completed: * BreastQ (baseline, wks 12, and 26) * PROMIS Questionnaire (baseline and wks 5, 12 and 26) * Medical Symptom Questionnaire (MSQ) (baseline and wks 5, 12 and 26) * Nutrition and Lifestyle Adherence Survey (randomization and then weekly for the duration of the study) * Dietary Supplementation Adherence Survey (only those randomized to SOC plus functional medicine; wk1 and then weekly for the duration of the study) Note: the BRA and SKIN surveys are not completed by the patient, but by the provider.
Number of Serious Adverse Events (SAE's).
Time frame: Up to 26 weeks
Number of Serious Adverse Events (SAE's).
71 secondary outcomes
Number of re-operations for wound management.
Time frame: Up to 26 weeks
Number of hospital re-admissions.
Time frame: Up to 26 weeks
Length-of-stay upon hospital re-admission.
Time frame: Up to 26 weeks
Number of antibiotic prescriptions.
Time frame: Up to 26 weeks
Correlate all post-operative complications with the predicted risk from the BRA scoring system.
Time frame: Up to 26 weeks
Correlate post-operative surgical site infection complications with the predicted risk from the BRA scoring system.
Time frame: Up to 26 weeks
Correlate post-operative seroma complications with the predicted risk from the BRA scoring system.
Time frame: Up to 26 weeks
Correlate post-operative dehiscence complications with the predicted risk from the BRA scoring system.
Time frame: Up to 26 weeks
Correlate post-operative flap loss complications with the predicted risk from the BRA scoring system.
Time frame: Up to 26 weeks
Correlate post-operative reoperation complications with the predicted risk from the BRA scoring system.
Time frame: Up to 26 weeks
Evaluate narcotic utilization while in the hospital.
Time frame: While in hospital, an average of 3 days
Evaluate narcotic utilization while in the hospital.
Time frame: While in hospital, an average of 3 days
Evaluate narcotic utilization while in the hospital.
Time frame: While in hospital, an average of 3 days
Evaluate narcotic utilization while in the hospital.
Time frame: While in hospital, an average of 3 days
Evaluate narcotic utilization while in the hospital.
Time frame: While in hospital, an average of 3 days
Evaluate narcotic utilization while in the hospital.
Time frame: While in hospital, an average of 3 days
Evaluate narcotic utilization while in the hospital.
Time frame: While in hospital, an average of 3 days
Evaluate narcotic utilization while in the hospital.
Time frame: While in hospital, an average of 3 days
Evaluate narcotic utilization while in the hospital.
Time frame: While in hospital, an average of 3 days
Change in Complete Blood Count with Differential (CBC).
Time frame: Baseline to 12 weeks
Change in Complete Blood Count with Differential (CBC).
Time frame: Baseline to 26 weeks
Change in Comprehensive Metabolic Pane (CMP).
Time frame: Baseline to 12 weeks
Change in Comprehensive Metabolic Pane (CMP).
Time frame: Baseline to 26 weeks
Change in Hemoglobin A1c (HbA1c).
Time frame: Baseline to 12 weeks
Change in Hemoglobin A1c (HbA1c).
Time frame: Baseline to 26 weeks
Change in nuclear magnetic resonance (NMR) LipoProfile.
Time frame: Baseline to 12 weeks
Change in NMR LipoProfile.
Time frame: Baseline to 26 weeks
Change in high-sensitivity C-Reactive Protein (hsCRP).
Time frame: Baseline to 12 weeks
Change in high-sensitivity C-Reactive Protein (hsCRP).
Time frame: Baseline to 26 weeks
Change in Vitamin D.
Time frame: Baseline to 12 weeks
Change in Vitamin D.
Time frame: Baseline to 26 weeks
Change in OmegaCheck.
Time frame: Baseline to 12 weeks
Change in OmegaCheck.
Time frame: Baseline to 26 weeks
Total healthcare costs.
Time frame: At 26 weeks
Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
Time frame: Baseline to week 12
Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
Time frame: Baseline to week 26
Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
Time frame: Baseline to week 5
Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
Time frame: Baseline to week 5
Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
Time frame: Baseline to week 12
Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
Time frame: Baseline to week 26
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No. No plans to share Individual Participant Data (IPD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Shallcross, ND, MPH principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed autologous breast reconstruction and Perioperative Functional Medicine (FM) Care in people with Breast Reconstruction, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility defined by percent randomized. (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.