PrehabilitationEarly Phase 1NCT04073381
Application of Ergogenic Aids to the Prehabilitation of Abdominal Cancer Patients Undergoing Cancer Surgery
A Early Phase 1 study testing Prehabilitation Program in people with Prehabilitation, run by University of Texas at Austin at 1 site in United States.
Trial summary
The purpose of the proposed study is to measure surgical recovery, including the length of hospital stay, incidence of perioperative complications, and mortality at 90 days post-surgery, in surgical patients with abdominal cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Prehabilitation
- What is being tested?
- Prehabilitation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2018to 31 Aug 2020
- Phase
- Early Phase 1
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients certified by a surgeon to participate in this study;
- Patients between the ages of 18 and 90;
- Patients with GI cancer.
Who cannot join
- Uncontrolled or active angina;
- New York Heart Association Class 3 or 4 heart failure;
- A myocardial infarction within the last 6 months;
- Severe/ uncontrolled hypertension (systolic pressure ≥180 mmHg or diastolic pressure ≥120mmHg);
- Uncontrolled diabetes (fasting blood glucose >400 mg/dL);
- American Society of Anesthesiologists (ASA) health status grade IV-V.
Show all 21Show fewer
- Severe orthopedic conditions that prohibit or impede exercise;
- Wheelchair dependence;
- Co-morbid medical conditions interfering with the ability to perform exercise; -Severely impaired ambulation (i.e. patients with uncontrolled neuromuscular disorders);
- History of Acute Deep Venous Thrombosis within the last 6 months;
- Inability to comply with exercise instructions upon evaluation; or
- Inability to provide an informed consent (dementia);
- Taking medication/supplements containing nitrites/nitrates;
- With allergies to creatine monohydrate;
- With allergies or intolerance to artificial sweeteners such as Sucralose, Xylitol, Aspartame, or Stevia;
- Simultaneous participation in a pharmacotherapy trial;
- Estimated glomerular filtration rate (EGFR) < 30 and not currently on dialysis.
- Pregnant or lactating women
- Dementia
- Mini Mental State Examination score of Severe Impairment (≤17), or
- Patients with severe depression.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Aging Research Laboratory at UT Austin
Austin, Texas, 78712
About this study
The purpose of the proposed study is to measure surgical recovery, including the length of hospital stay, incidence of perioperative complications, and mortality at 90 days post-surgery, in surgical patients with abdominal cancer. The investigators hypothesize that this prehabilitation program will improve recovery and reduce perioperative complications via the proposed prehabilitation intervention.
Read the detailed description
The investigators propose that steps to augment and optimize the effectiveness of prehabilitation interventions for abdominal cancer patients may be found in the field of sport science. The investigators have identified two primary strategies to improve and optimize prehabilitation in patients with abdominal cancer: exercise and nutritional supplementation. A home-based exercise program incorporating both walking and resistance training will be performed with blood flow restriction training (BFR). BFR is a cutting-edge training modality that works by restricting blood flow out of the veins by using compression devices similar to traditional blood pressure cuffs (1). This training modality is frequently used by injured athletes for enhanced recovery (2). Muscle hypertrophy and increased muscle strength are more robust and achievable with BFR, even if exercises are performed at low to moderate intensities (2). Additionally, the implementation of a sports nutrition supplement cocktail, which will be provided simultaneously with the 4-week BFR exercise intervention, was developed to augment the effects of resistance exercise by increasing overall anabolism (3) and to remedy the catabolic state that cancer patients often experience (4). The nutrition supplement cocktail will include whey protein, creatine monohydrate, and L-citrulline.
- Conditions
- Prehabilitation
- Being tested
- Prehabilitation Program
- Keywords
- Blood Flow Restriction Training, Ergogenic Aids, Abdominal Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation ProgramCombination product
This is a 4 week prehabilitation program which uses both exercise and nutrition. Exercise will be prescribed at least 6 days a week. Three days a week , for 45 mins, participants will be asked to perform body, leg and arm exercises against light resistance while wearing pneumatic blood flow restriction arm and leg bands. minutes. On the alternate days participants will walk approximately 15 minutes while wearing the leg bands that restrict blood flow. Additionally, a nutrition supplement cocktail will be provided and should be taken every day within 1 hour after completing each exercise session. The 4 Week Nutrition (Sports Drink) Supplement Cocktail: will include whey protein (25 g/day), creatine monohydrate (8 g/day), and L-citrulline (5 g/day). The supplement mixture will be provided in daily packages by the investigators (nutrition supplements are not regulated by the FDA)
| Study group | Role | What they receive |
|---|---|---|
| Prehabiliation Program | Experimental | 100 subjects between the ages of 18 and 90, who have GI cancer and will undergo surgery will be recruited for this study ad participate in the prescribed prehabilitation exercise and nutrition program. Receives: Combination Product: Prehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Measures- Length of hospital stay
Length of hospital stay
Measured: Through study completion, an average 1year
Hospital Measures- Emergency room visits
emergency room visits
Measured: Through study completion, an average 1 year
Hospital Measures- Readmission
Readmission
Measured: Through study completion, an average 1 year
Hospital Measures
Mortality
Measured: Through study completion, an average 1 year
Secondary outcomes (21)
Physical Fitness- Hand Grip
Hand grip dynamometry
Measured: Baseline, 4 weeks, and 8 weeks
Physical Fitness- 6MWT
6 minute walk test
Measured: Baseline and 4 weeks
Physical Fitness- TUG
Timed up and go
Measured: Baseline, 4 weeks, and 8 weeks
Physical Fitness- SPPB
Short Physical Performance Battery Assessing Lower Extremity Function
Measured: Baseline and 4 weeks
Body Composition
DXA (dual energy X-ray absorptiometry) will be used to assess body composition.
Measured: Baseline and 4 weeks
Blood Work- AA
Amino Acids
Measured: Baseline and 4 weeks
Blood Work- CRP
C-Reactive protein (CRP)
Measured: Baseline and 4 weeks
Blood Work- IL6
Interleukin 6 (IL-6)
Measured: Baseline and 4 weeks
Blood Work- TNFalpha
TNF-alpha
Measured: Baseline and 4 weeks
Questionnaires- Health Status
Health research questionnaire; self reported medical and health history of participant.
Measured: Baseline
Questionnaires- IPAQ
International Physical Activity Questionnaire; self reported time, frequency and duration of physical activity within the last 7 days.
Measured: Baseline and 8 weeks
Questionnaires- SF36
SF-36 Quality of Life. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Baseline, 4 weeks, and 8 weeks
Questionnaires- MMSE
Mini Mental State Examination (MMSE) 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Score is reported as 0-30 . 24-30 indicates no cognitive impairment, 18-23 indicates mild cognitive impairment, and 0-17 indicates severe cognitive impairment.
Measured: Baseline
Questionnaires- FESI
Falls Efficacy Scale-International; items are summed to calculate a range of total score from minimum 16 to maximum 64. The higher the score the greater the fear of falling.
Measured: Baseline, 4 weeks, and 8 weeks
Questionnaires- Nutrition
Dietary Food and Supplement Intake; self reported nutrition intake from 2 weekdays and one weekend.
Measured: Baseline
Questionnaires- Charlson Comorbidity
Charlson Comorbidity Index predicts the one-year mortality for a patient who may have a range of comorbid conditions, such as heart disease, AIDS, or cancer (a total of 22 conditions). Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one. Scores are summed to provide a total score to predict mortality.
Measured: Baseline
Questionnaires- BSCI
Brief Screen for Cognitive Impairment (BSCI); Scores are weighted and summed to arrive at final score. Delayed recall and medication help each get a weight of 2.0, and errand help gets a weight of 1.0. If client does not take any medications, the weighted scores of the other two items perform similarly to the three-item version. Higher scores indicate greater frailty/cognitive impairment.
Measured: Baseline
Questionnaires- Edmonton Frailty
Edmonton Frailty Assessment; consists of nine domains and eleven items, each scoring 0 points (frailty absent or normal health), 1 point (minor errors or mild/moderate impairment), or 2 points (important errors or severely impaired). Higher scores indicate greater frailty.
Measured: Baseline
Questionnaires- ECOG
Eastern Cooperative Oncology Group Performance Status; Determines ability of patient to tolerate therapies in serious illness, specifically for chemotherapy.
Measured: Baseline
Questionnaires- Clock Test
Clock Test; evaluates three items: "correctly drawn clock shape," "all numbers in the correct position," and "hands of the clock set to the correct time." A score of 1 was assigned for each of these items. Higher scores indicate greater frailty/cognitive impairment.
Measured: Baseline
Accerlometry
Accelerometer/ Pedometer Measurement will be used to measure activity levels for 7 days immediately post surgery.
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start28 Oct 2018
- Primary completion31 Jul 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrehabilitationStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 100 subjects between the ages of 18 and 90, who have GI cancer and will undergo surgery will be recruited for this study. 100 is an arbitrary number of participants. Due to this study design not being previously use before power analysis calculations were unable to made for key variables. All subjects will participate in the study design.
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hirofumi Tanaka, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073381
- Sponsor's protocol ID
- 2018-08-0110
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2019
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be reported as average group means.
Publications
Wooten SV, Wolf JS Jr, Mendoza D, Bartholomew JB, Stanforth PR, Stanforth D, Tanaka H, Fleming RYD. The Impact of a Multimodal Sport Science-Based Prehabilitation Program on Clinical Outcomes in Abdominal Cancer Patients: A Cohort Study. Am Surg. 2022 Sep;88(9):2302-2308. doi: 10.1177/00031348221103657. Epub 2022 May 24.
PubMed 35608376
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Ergogenic Aids to the Prehabilitation of Abdominal Cancer Patients Undergoing Cancer Surgery
- ClinicalTrials.gov ID
- NCT04073381
- Acronym / sponsor ID
- 2018-08-0110
- Conditions
- Prehabilitation
- Keywords
- Blood Flow Restriction Training, Ergogenic Aids, Abdominal Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 28 Oct 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 29 Aug 2019 (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.
The purpose of the proposed study is to measure surgical recovery, including the length of hospital stay, incidence of perioperative complications, and mortality at 90 days post-surgery, in surgical patients with abdominal cancer. The investigators hypothesize that this prehabilitation program will improve recovery and reduce perioperative complications via the proposed prehabilitation intervention.
Detailed description
The investigators propose that steps to augment and optimize the effectiveness of prehabilitation interventions for abdominal cancer patients may be found in the field of sport science. The investigators have identified two primary strategies to improve and optimize prehabilitation in patients with abdominal cancer: exercise and nutritional supplementation. A home-based exercise program incorporating both walking and resistance training will be performed with blood flow restriction training (BFR). BFR is a cutting-edge training modality that works by restricting blood flow out of the veins by using compression devices similar to traditional blood pressure cuffs (1). This training modality is frequently used by injured athletes for enhanced recovery (2). Muscle hypertrophy and increased muscle strength are more robust and achievable with BFR, even if exercises are performed at low to moderate intensities (2). Additionally, the implementation of a sports nutrition supplement cocktail, which will be provided simultaneously with the 4-week BFR exercise intervention, was developed to augment the effects of resistance exercise by increasing overall anabolism (3) and to remedy the catabolic state that cancer patients often experience (4). The nutrition supplement cocktail will include whey protein, creatine monohydrate, and L-citrulline.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 100 subjects between the ages of 18 and 90, who have GI cancer and will undergo surgery will be recruited for this study. 100 is an arbitrary number of participants. Due to this study design not being previously use before power analysis calculations were unable to made for key variables. All subjects will participate in the study design.
| Arm | Type | Receives |
|---|---|---|
| Prehabiliation Program | Experimental | Combination Product: Prehabilitation Program100 subjects between the ages of 18 and 90, who have GI cancer and will undergo surgery will be recruited for this study ad participate in the prescribed prehabilitation exercise and nutrition program. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients certified by a surgeon to participate in this study;
- Patients between the ages of 18 and 90;
- Patients with GI cancer.
Key exclusion criteria (21 listed)
- Uncontrolled or active angina;
- New York Heart Association Class 3 or 4 heart failure;
- A myocardial infarction within the last 6 months;
- Severe/ uncontrolled hypertension (systolic pressure ≥180 mmHg or diastolic pressure ≥120mmHg);
- Uncontrolled diabetes (fasting blood glucose >400 mg/dL);
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 |
|---|---|---|
| Prehabilitation ProgramThis is a 4 week prehabilitation program which uses both exercise and nutrition. Exercise will be prescribed at least 6 days a week. Three days a week , for 45 mins, participants will be asked to perform body, leg and arm exercises against light resistance while wearing pneumatic blood flow restriction arm and leg bands. minutes. On the alternate days participants will walk approximately 15 minutes while wearing the leg bands that restrict blood flow. Additionally, a nutrition supplement cocktail will be provided and should be taken every day within 1 hour after completing each exercise session. The 4 Week Nutrition (Sports Drink) Supplement Cocktail: will include whey protein (25 g/day), creatine monohydrate (8 g/day), and L-citrulline (5 g/day). The supplement mixture will be provided in daily packages by the investigators (nutrition supplements are not regulated by the FDA) | Combination product | Prehabiliation Program |
Primary outcome
Hospital Measures- Length of hospital stay
Time frame: Through study completion, an average 1year
Length of hospital stay
Hospital Measures- Emergency room visits
Time frame: Through study completion, an average 1 year
emergency room visits
Hospital Measures- Readmission
Time frame: Through study completion, an average 1 year
Readmission
Hospital Measures
Time frame: Through study completion, an average 1 year
Mortality
21 secondary outcomes
Physical Fitness- Hand Grip
Time frame: Baseline, 4 weeks, and 8 weeks
Physical Fitness- 6MWT
Time frame: Baseline and 4 weeks
Physical Fitness- TUG
Time frame: Baseline, 4 weeks, and 8 weeks
Physical Fitness- SPPB
Time frame: Baseline and 4 weeks
Body Composition
Time frame: Baseline and 4 weeks
Blood Work- AA
Time frame: Baseline and 4 weeks
Blood Work- CRP
Time frame: Baseline and 4 weeks
Blood Work- IL6
Time frame: Baseline and 4 weeks
Blood Work- TNFalpha
Time frame: Baseline and 4 weeks
Questionnaires- Health Status
Time frame: Baseline
Questionnaires- IPAQ
Time frame: Baseline and 8 weeks
Questionnaires- SF36
Time frame: Baseline, 4 weeks, and 8 weeks
Questionnaires- MMSE
Time frame: Baseline
Questionnaires- FESI
Time frame: Baseline, 4 weeks, and 8 weeks
Questionnaires- Nutrition
Time frame: Baseline
Questionnaires- Charlson Comorbidity
Time frame: Baseline
Questionnaires- BSCI
Time frame: Baseline
Questionnaires- Edmonton Frailty
Time frame: Baseline
Questionnaires- ECOG
Time frame: Baseline
Questionnaires- Clock Test
Time frame: Baseline
Accerlometry
Time frame: Through study completion, an average of one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Derived from this study: PubMed 35608376Wooten SV, Wolf JS Jr, Mendoza D, Bartholomew JB, Stanforth PR, Stanforth D, Tanaka H, Fleming RYD. The Impact of a Multimodal Sport Science-Based Prehabilitation Program on Clinical Outcomes in Abdominal Cancer Patients: A Cohort Study. Am Surg. 2022 Sep;88(9):2302-2308. doi: 10.1177/00031348221103657. Epub 2022 May 24.
- Individual participant dataSharing planned: No. Data will be reported as average group means.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Prehabilitation Program in people with Prehabilitation, run by University of Texas at Austin 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 3 inclusion and 21 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: finished, as of the sponsor's last update on 8 Jul 2021. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hospital Measures- Length of hospital stay (time frame: Through study completion, an average 1year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04073381, which also lists 1 linked publication.
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 8 Jul 2021.