Measuring muscle health in breast and gynecological cancer patients using near infrared spectroscopy
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
Run by University of South Carolina · NCT06672497 · Data updated 2026-11-12
This study is testing how chemotherapy affects muscle health in breast and gynecological cancer patients by checking their muscle function during exercise.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 20 Years and up |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | University of South Carolina Academic / other |
| Drugs / interventions | chemotherapy, cart |
| Locations | 1 site (Greenville, South Carolina) |
| Status | Recruiting |
| Started | September 7, 2021 |
| Main results expected | August 2025 |
| Study ends | March 2026 |
| Registry record updated | November 4, 2024 |
| Trial ID | NCT06672497 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients diagnosed with non-metastatic breast or gynecological cancer who can perform moderate exercise.
✕Probably not a fit
Patients with metastatic cancer or significant cardiovascular or pulmonary diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study recruits breast cancer and gynecological cancer patients to assess the impact of chemotherapy on muscle mitochondrial oxidative capacity. Participants will engage in a controlled exercise session on a stationary bicycle while their quadriceps muscle is evaluated non-invasively using near infrared spectroscopy (NIRS). The study aims to measure changes in oxygenation and deoxygenation status of the muscle, which reflects mitochondrial function, after exercise. Testing will occur at the University of South Carolina's Human Performance Laboratory, with each session lasting approximately 30 minutes.
Why it matters
Potential benefit: If successful, this study could provide insights into the effects of chemotherapy on muscle health, potentially leading to improved management strategies for cancer patients.
How similar studies have gone: While the use of NIRS in assessing muscle oxidative capacity is established, this specific application in cancer patients is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Movement disorders * Spinal cord injuries * Autoimmune disorders * Pregnant or breastfeeding * Mini-Mental State Examination (MMSE) \<24
Where it's running
-
Prisma Health Cancer Institute
Greenville, South Carolina, United States Recruiting
Study contacts
- Principal investigator: Jennifer L Trilk, PhD — University of South Carolina School of Medicine, Greenville
- Study coordinator: Jennifer L Trilk, PhD
- Email: trilk@greenvillemed.sc.edu
- Phone: 864-455-1410
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.