RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-09-07
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06672497

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients diagnosed with breast cancer or gynecological cancer without distance metastasis
  2. * Able to perform exercise on a stationary cycle ergometer at moderate intensities for a maximum of 15 minutes
  3. * Hemoglobin values greater than 10 at baseline
  4. * ALT and AST values less than 2.5X the upper limit of normal by institutional standards
  5. * 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
  1. * Metastatic breast or gynecological cancer
  2. * Clinically advanced cardiovascular disease
  3. * Clinically advanced pulmonary disease
  4. * Disease requiring continuous oxygen supplementation
  5. * Greater than 2 centimeters or more of subcutaneous adipose tissue on the anterior thigh
  6. * Inability to walk or stand
  7. * Movement disorders
  8. * Spinal cord injuries
  9. * Autoimmune disorders
  10. * Pregnant or breastfeeding
  11. * Mini-Mental State Examination (MMSE) \<24

Contacts and Locations

Study Contact

Jennifer L Trilk, PhD
CONTACT
864-455-1410
trilk@greenvillemed.sc.edu
Frankie Bennett, MS
CONTACT
864-455-1410
bennet24@greenvillemed.sc.edu

Principal Investigator

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

Study Locations (Sites)

Prisma Health Cancer Institute
Greenville, South Carolina, 29605
United States

Collaborators and Investigators

Sponsor: University of South Carolina

  • 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-07
Study Completion Date2026-03

Study Record Updates

Study Start Date2021-09-07
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • nirs
  • mitochondrial oxidative capacity
  • muscle oxidative capacity
  • breast cancer
  • gynecological cancer
  • near infrared spectroscopy

Additional Relevant MeSH Terms

  • Breast Cancer
  • Gynecologic Cancers
  • Mitochondrial Function