Clinical trial Recruiting at 1 site Observational Ages 20 and up Women only

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.

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Quick facts

Study typeObservational
Ages20 Years and up
SexWomen only
Enrollment30 (estimated)
SponsorUniversity of South Carolina
Academic / other
Drugs / interventionschemotherapy, cart
Locations1 site (Greenville, South Carolina)
StatusRecruiting
StartedSeptember 7, 2021
Main results expectedAugust 2025
Study endsMarch 2026
Registry record updatedNovember 4, 2024
Trial IDNCT06672497 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.