Breast CancerNCT06672497
Near Infrared Spectroscopy (NIRS) as a Method for Measuring Oxidative Capacity of Skeletal Muscle Mitochondria in Breast Cancer and All Gynecological Cancer Patients
An observational study of Breast Cancer and Gynecologic Cancers, run by University of South Carolina at 1 site in United States.
Trial summary
Participants recruited for this study will be breast cancer or gynecological cancer patients who agree to participate in an exercise study examining the effects of chemotherapy on muscle mitochondrial oxidative capacity, a measure of skeletal muscle health. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer, Gynecologic Cancers, Mitochondrial Function
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2021to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study focuses on breast cancer or gynecological cancer patients who will undergo a standard of care chemotherapy treatment as directed by their oncologist.
Who may be able to join
- Patients diagnosed with breast cancer or gynecological cancer without distance metastasis
- Able to perform exercise on a stationary cycle ergometer at moderate intensities for a maximum of 15 minutes
- Hemoglobin values greater than 10 at baseline
- ALT and AST values less than 2.5X the upper limit of normal by institutional standards
- Godin-Shepard Leisure time Physical Activity Questionnaire (GLTEQ) score of 14 or greater will be included. A score of less than 14 is considered insufficiency active/sedentary
Who cannot join
- Metastatic breast or gynecological cancer
- Clinically advanced cardiovascular disease
- Clinically advanced pulmonary disease
- Disease requiring continuous oxygen supplementation
- Greater than 2 centimeters or more of subcutaneous adipose tissue on the anterior thigh
- Inability to walk or stand
Show all 11Show fewer
- Movement disorders
- Spinal cord injuries
- Autoimmune disorders
- Pregnant or breastfeeding
- Mini-Mental State Examination (MMSE) <24
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Prisma Health Cancer Institute
Greenville, South Carolina, 29605
Frankie Bennett, MS, 864-455-1410, bennet24@greenvillemed.sc.edu
James Rosemeyer, MS, 864-455-1410, rosemeyj@greenvillemed.sc.edu
About this study
Participants recruited for this study will be breast cancer or gynecological cancer patients who agree to participate in an exercise study examining the effects of chemotherapy on muscle mitochondrial oxidative capacity, a measure of skeletal muscle health. Participants will ride a stationary bicycle and the quadriceps muscle will be non-invasively evaluated.
Read the detailed description
The NIRS participant testing will be performed in the University of South Carolina School of Medicine Greenville's Human Performance Laboratory located within Cancer Institute Faris Road facility. Testing will take approximately 30 minutes per session, with a maximum of 180 minutes of participation per patient. The independent variables in this study are drug regimen and number of chemotherapy treatments. The dependent variables in this study will be the change in oxygenation and deoxygenation status of the vastus lateralis as measured by the NIRS device, indicative of mitochondrial oxidative capacity, after a bout of cycling. Patients will be asked to avoid exercise and use of certain substances (tobacco, alcohol, caffeine, and contraindicated medications) 24 hours prior to testing.
Participants will be asked to perform exercise in shorts or equivalent. Participants will first sit at rest in a chair, as the NIRS device is applied to the vastus lateralis. The device will have double sided adhesive tape to lightly secure its position to the skin. The device will be wrapped in a black cloth to fully secure its position, limit device mobility, and block ambient light in the laboratory. Participants will then stand and walk to the cycle with the NIRS secured to the participant's leg. Participants will sit on the bike for a 2-minute rest while wearing a fitted mask that comfortably measures the participant's rate and amount of oxygen uptake (VO2) and other ventilatory measurements at rest and during exercise.
Researchers will determine the participant's lactate threshold curve and ventilatory threshold during a graded exercise test. The lactate threshold is a measure of the rate at which capillary blood lactate measurements rise as an effect of increased exercise intensity. The blood lactate curve will be used to determine an individualized power wattage for subsequent exercise testing of "on-off kinetics" (see below description). Capillary blood lactate levels will be obtained by finger stick for point of care testing. Ventilatory threshold will be measured using indirect calorimetry via a metabolic cart that captures expired gasses (O2 and CO2) through a comfortable silicone mask worn by the participant.
A baseline blood lactate level will be obtained at rest, then the participant will be instructed to cycle for three minutes beginning at 10W. After the 3-minute stage is complete, the power output will increase by 15 watts. The participant will cycle for 3 minutes at each stage until their lactate threshold reaches 4.0 mmol/L. Once the blood lactate reaches 4.0 mmol/L, one final, three-minute stage will be performed. A final lactate reading will be obtained at the completion of this exercise stage. The power output that is equivalent to 1.1x the wattage at which their lactate threshold exceeded 4.0 mmol/L will be used as the exercise intensity ("on-kinetics") for subsequent visits accompanying chemotherapy treatments.
Participants will return for each subsequent visit within a week before their next chemotherapy infusion as long as they are able to safely continue the exercise protocol. The NIRS device will be secured to the participant's leg similar to the first visit and the participants will put on the mask to measure ventilation. Participants will begin pedaling for a warmup at 0 watts for 2 minutes. After the two-minute warm up period is completed, the power output will increase to the previously calculated wattage of 1.1x LT. The participant will cycle at a self-selected cadence at this power wattage for a duration of 2 minutes ("on-kinetics"). At the end of each on-kinetics stage, participants will be asked to rate their level of effort during exercise, Rate of Perceived Exertion (RPE). The participant will then stop pedaling and will remain in recovery, sitting on the bike for 2 minutes ("off-kinetics" stage). With 5 seconds remaining in the "off-kinetics" stage, the participant will start pedaling at the same self-selected cadence for their next "on-kinetics" stage, followed by another 2-min "off-kinetics" period. This cycle of exercise followed by rest, known as on-off kinetics, will repeat for a total maximum of 3 times, or until the participant reaches volitional fatigue.
The investigators will be administering MoCA, BFI, Physical Activity Intake, PROMIS Global Health, and GLTPAQ surveys prior to participant engagement in cycling exercises. The investigators will also be administering BFI, PROMIS Global Health, and Physical Activity Follow-up surveys after each individual study session to assess changes in cancer related fatigue associated with chemotherapy treatment that may develop throughout the study time period.
Participants will undergo routine, standard of care blood draws for a CBC and metabolic testing per their managing physician with an additional tube, during the same venipuncture, for a study covered aliquot for biomarkers related to mitochondrial health for correlative research.
- Conditions
- Breast Cancer, Gynecologic Cancers, Mitochondrial Function
- Keywords
- nirs, mitochondrial oxidative capacity, muscle oxidative capacity, breast cancer, gynecological cancer, near infrared spectroscopy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with breast or gynecological cancer and undergoing neoadjuvant chemotherapy. | Females ages 20... |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mitochondrial oxidative capacity
Study staff will measure O2Hb, HHb, and TSI, via the NIRS PortaMon device during the on-off kinetics protocol.
Measured: From enrollment to the end of chemotherapy treatment, an average of 12 weeks
Secondary outcomes (1)
Whole body oxygen uptake via indirect calorimetry
We also will measure ventilatory whole-body components including O2 and CO2 via the Parvomedics metabolic cart.
Measured: From enrollment to the end of chemotherapy treatment, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start7 Sep 2021
- Primary completionAug 2025 (estimated)
- Study completionMar 2026 (estimated)
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Furman University, Prisma Health-Upstate
- Responsible party
- Principal investigator, Jennifer Trilk, University of South Carolina
- Investigators
- Jennifer L Trilk, PhD, Principal investigator, University of South Carolina School of Medicine, GreenvilleRandolph Hutchison, PhD, Principal investigator, Furman UniversityLarry Gluck, MD, Principal investigator, Prisma Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672497
- Sponsor's protocol ID
- 1853511
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hutchison RE, Smith S, Caudell C, Biddle S, Gluck WL, Trilk JL. Effects of chemotherapy on skeletal muscle mitochondrial oxidative capacity using near-infrared spectroscopy (NIRS): Protocol paper for an observational mixed model repeated measures design in patients with breast and gynecological cancer. PLoS One. 2025 Jun 27;20(6):e0315351. doi: 10.1371/journal.pone.0315351. eCollection 2025.
PubMed 40577323
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near Infrared Spectroscopy (NIRS) as a Method for Measuring Oxidative Capacity of Skeletal Muscle Mitochondria in Breast Cancer and All Gynecological Cancer Patients
- ClinicalTrials.gov ID
- NCT06672497
- Acronym / sponsor ID
- 1853511
- Conditions
- Breast Cancer, Gynecologic Cancers, Mitochondrial Function
- Keywords
- nirs, mitochondrial oxidative capacity, muscle oxidative capacity, breast cancer, gynecological cancer, near infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Furman University, Prisma Health-Upstate
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 4 Nov 2024 (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.
Participants recruited for this study will be breast cancer or gynecological cancer patients who agree to participate in an exercise study examining the effects of chemotherapy on muscle mitochondrial oxidative capacity, a measure of skeletal muscle health. Participants will ride a stationary bicycle and the quadriceps muscle will be non-invasively evaluated.
Detailed description
The NIRS participant testing will be performed in the University of South Carolina School of Medicine Greenville's Human Performance Laboratory located within Cancer Institute Faris Road facility. Testing will take approximately 30 minutes per session, with a maximum of 180 minutes of participation per patient. The independent variables in this study are drug regimen and number of chemotherapy treatments. The dependent variables in this study will be the change in oxygenation and deoxygenation status of the vastus lateralis as measured by the NIRS device, indicative of mitochondrial oxidative capacity, after a bout of cycling. Patients will be asked to avoid exercise and use of certain substances (tobacco, alcohol, caffeine, and contraindicated medications) 24 hours prior to testing.
Participants will be asked to perform exercise in shorts or equivalent. Participants will first sit at rest in a chair, as the NIRS device is applied to the vastus lateralis. The device will have double sided adhesive tape to lightly secure its position to the skin. The device will be wrapped in a black cloth to fully secure its position, limit device mobility, and block ambient light in the laboratory. Participants will then stand and walk to the cycle with the NIRS secured to the participant's leg. Participants will sit on the bike for a 2-minute rest while wearing a fitted mask that comfortably measures the participant's rate and amount of oxygen uptake (VO2) and other ventilatory measurements at rest and during exercise.
Researchers will determine the participant's lactate threshold curve and ventilatory threshold during a graded exercise test. The lactate threshold is a measure of the rate at which capillary blood lactate measurements rise as an effect of increased exercise intensity. The blood lactate curve will be used to determine an individualized power wattage for subsequent exercise testing of "on-off kinetics" (see below description). Capillary blood lactate levels will be obtained by finger stick for point of care testing. Ventilatory threshold will be measured using indirect calorimetry via a metabolic cart that captures expired gasses (O2 and CO2) through a comfortable silicone mask worn by the participant.
A baseline blood lactate level will be obtained at rest, then the participant will be instructed to cycle for three minutes beginning at 10W. After the 3-minute stage is complete, the power output will increase by 15 watts. The participant will cycle for 3 minutes at each stage until their lactate threshold reaches 4.0 mmol/L. Once the blood lactate reaches 4.0 mmol/L, one final, three-minute stage will be performed. A final lactate reading will be obtained at the completion of this exercise stage. The power output that is equivalent to 1.1x the wattage at which their lactate threshold exceeded 4.0 mmol/L will be used as the exercise intensity ("on-kinetics") for subsequent visits accompanying chemotherapy treatments.
Participants will return for each subsequent visit within a week before their next chemotherapy infusion as long as they are able to safely continue the exercise protocol. The NIRS device will be secured to the participant's leg similar to the first visit and the participants will put on the mask to measure ventilation. Participants will begin pedaling for a warmup at 0 watts for 2 minutes. After the two-minute warm up period is completed, the power output will increase to the previously calculated wattage of 1.1x LT. The participant will cycle at a self-selected cadence at this power wattage for a duration of 2 minutes ("on-kinetics"). At the end of each on-kinetics stage, participants will be asked to rate their level of effort during exercise, Rate of Perceived Exertion (RPE). The participant will then stop pedaling and will remain in recovery, sitting on the bike for 2 minutes ("off-kinetics" stage). With 5 seconds remaining in the "off-kinetics" stage, the participant will start pedaling at the same self-selected cadence for their next "on-kinetics" stage, followed by another 2-min "off-kinetics" period. This cycle of exercise followed by rest, known as on-off kinetics, will repeat for a total maximum of 3 times, or until the participant reaches volitional fatigue.
The investigators will be administering MoCA, BFI, Physical Activity Intake, PROMIS Global Health, and GLTPAQ surveys prior to participant engagement in cycling exercises. The investigators will also be administering BFI, PROMIS Global Health, and Physical Activity Follow-up surveys after each individual study session to assess changes in cancer related fatigue associated with chemotherapy treatment that may develop throughout the study time period.
Participants will undergo routine, standard of care blood draws for a CBC and metabolic testing per their managing physician with an additional tube, during the same venipuncture, for a study covered aliquot for biomarkers related to mitochondrial health for correlative research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with breast or gynecological cancer and undergoing neoadjuvant chemotherapy. | – | –Females ages 20... |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study focuses on breast cancer or gynecological cancer patients who will undergo a standard of care chemotherapy treatment as directed by their oncologist.
Key inclusion criteria (5 listed)
- Patients diagnosed with breast cancer or gynecological cancer without distance metastasis
- Able to perform exercise on a stationary cycle ergometer at moderate intensities for a maximum of 15 minutes
- Hemoglobin values greater than 10 at baseline
- ALT and AST values less than 2.5X the upper limit of normal by institutional standards
- Godin-Shepard Leisure time Physical Activity Questionnaire (GLTEQ) score of 14 or greater will be included. A score of less than 14 is considered insufficiency active/sedentary
Key exclusion criteria (11 listed)
- Metastatic breast or gynecological cancer
- Clinically advanced cardiovascular disease
- Clinically advanced pulmonary disease
- Disease requiring continuous oxygen supplementation
- Greater than 2 centimeters or more of subcutaneous adipose tissue on the anterior thigh
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle mitochondrial oxidative capacity
Time frame: From enrollment to the end of chemotherapy treatment, an average of 12 weeks
Study staff will measure O2Hb, HHb, and TSI, via the NIRS PortaMon device during the on-off kinetics protocol.
1 secondary outcome
Whole body oxygen uptake via indirect calorimetry
Time frame: From enrollment to the end of chemotherapy treatment, an average of 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Derived from this study: PubMed 40577323Hutchison RE, Smith S, Caudell C, Biddle S, Gluck WL, Trilk JL. Effects of chemotherapy on skeletal muscle mitochondrial oxidative capacity using near-infrared spectroscopy (NIRS): Protocol paper for an observational mixed model repeated measures design in patients with breast and gynecological cancer. PLoS One. 2025 Jun 27;20(6):e0315351. doi: 10.1371/journal.pone.0315351. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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.
Jennifer L Trilk, PhD principal investigator
University of South Carolina School of Medicine, Greenville
Randolph Hutchison, PhD principal investigator
Furman University
Larry Gluck, MD principal investigator
Prisma Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Gynecologic Cancers, run by University of South Carolina 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 4 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer L Trilk, PhD (864-455-1410, trilk@greenvillemed.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mitochondrial oxidative capacity (time frame: From enrollment to the end of chemotherapy treatment, an average of 12 weeks). 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 NCT06672497, 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 4 Nov 2024.