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Observational Study of Muscle Health in Breast and Gynecologic Cancers

This study is looking at how chemotherapy affects the health of your muscles, specifically how well your muscle cells (mitochondria) use oxygen. This is called mitochondrial oxidative capacity. If you have breast cancer or a gynecologic cancer that hasn't spread far, you might be able to join. You'll ride a stationary bike, and a special device (Near Infrared Spectroscopy or NIRS) will non-invasively measure changes in your thigh muscle. The study aims to understand how chemotherapy treatments impact this muscle health. The study is currently unclear on its recruitment status.

Study design
This is an observational study with 30 participants. It is not testing a new drug or treatment.
What's involved
You will have up to 180 minutes of participation, with each session lasting about 30 minutes. You'll ride a stationary bicycle and have a device attached to your leg.
Compensation
Not stated in the trial record.
Follow-up
Muscle mitochondrial oxidative capacity will be measured from enrollment to the end of chemotherapy treatment, an average of 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06672497

Near Infrared Spectroscopy (NIRS) as a Method for Measuring Oxidative Capacity of Skeletal Muscle Mitochondria in Breast Cancer and All Gynecological Cancer Patients

Recruiting
Not specifiedAges 20+Observational
University of South Carolina
~30 participants
Updated 2024-11-04 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Muscle mitochondrial oxidative capacity
Measured over From enrollment to the end of chemotherapy treatment, an average of 12 weeks

Conditions

Breast Cancer
Gynecologic Cancers
Mitochondrial Function

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Breast CarcinomaMalignant Female Reproductive System Neoplasm

Where it's being run

1 sites across 1 states
South Carolina1

Study leadership

  • 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

Who to contact

Jennifer L Trilk, PhD
[email protected]
864-455-1410
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Muscle mitochondrial oxidative capacityFrom 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.