Recruiting

Observational Study

Sponsor:

University of South Carolina

Code:

NCT06672497

Conditions

Breast Cancer

Gynecologic Cancers

Mitochondrial Function

Eligibility Criteria

Sex: Female

Age: 20+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Breast Cancer

Gynecologic Cancers

Mitochondrial Function

Study ID

NCT06672497

Start date

Sep 7, 2021

Status verified date

Nov, 2024

Completion date

Mar, 2026

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients diagnosed with breast or gynecological cancer and undergoing neoadjuvant chemotherapy.

Females ages 20...

Primary outcome measure

  • Muscle mitochondrial oxidative capacity [ Time Frame: From enrollment to the end of chemotherapy treatment, an average of 12 weeks ]

Central Contacts and Locations

Central contacts

Jennifer L Trilk, PhD

864-455-1410trilk@greenvillemed.sc.edu

Frankie Bennett, MS

864-455-1410bennet24@greenvillemed.sc.edu

Locations

Prisma Health Cancer Institute

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Frankie Bennett, MS

864-455-1410bennet24@greenvillemed.sc.edu

James Rosemeyer, MS

864-455-1410rosemeyj@greenvillemed.sc.edu

Principal Investigator:

Jennifer L Trilk, PhD

More Information

Sponsor

University of South Carolina

Last update posted

Nov 4, 2024

Last verified

Nov, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Carolina on 2024-11-04.