Measuring muscle health in breast and gynecological cancer patients using near infrared spectroscopy
Near Infrared Spectroscopy (NIRS) as a Method for Measuring Oxidative Capacity of Skeletal Muscle Mitochondria in Breast Cancer and All Gynecological Cancer Patients
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 |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | University of South Carolina Academic / other |
| Drugs / interventions | chemotherapy, cart |
| Locations | 1 site (Greenville, South Carolina) |
| Trial ID | NCT06672497 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with non-metastatic breast or gynecological cancer who can perform moderate exercise.
Not a fit: Patients with metastatic cancer or significant cardiovascular or pulmonary diseases may not benefit from this study.
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 performed: While the use of NIRS in assessing muscle oxidative capacity is established, this specific application in cancer patients is relatively novel.
Eligibility criteria
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 this trial is running
Greenville, South Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.