NCT06672497 Near Infrared Spectroscopy (NIRS) as a Method for Measuring Oxidative Capacity of Skeletal Muscle Mitochondria in Breast Cancer and All Gynecological Cancer Patients
| NCT ID | NCT06672497 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of South Carolina |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-09-07 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2021-09-07 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. Participants will ride a stationary bicycle and the quadriceps muscle will be non-invasively evaluated.
Eligibility 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
Contact & Investigator
Jennifer L Trilk, PhD
PRINCIPAL INVESTIGATOR
University of South Carolina School of Medicine, Greenville
Frequently Asked Questions
Who can join the NCT06672497 clinical trial?
This trial is open to female participants only, aged 20 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06672497 currently recruiting?
Yes, NCT06672497 is actively recruiting participants. Contact the research team at trilk@greenvillemed.sc.edu for enrollment information.
Where is the NCT06672497 trial being conducted?
This trial is being conducted at Greenville, United States.
Who is sponsoring the NCT06672497 clinical trial?
NCT06672497 is sponsored by University of South Carolina. The principal investigator is Jennifer L Trilk, PhD at University of South Carolina School of Medicine, Greenville. The trial plans to enroll 30 participants.
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