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

NCT06672497 | Recruiting DMC

• 1 other identifier: 1853511
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Muscle mitochondrial oxidative capacity

  Study staff will measure O2Hb, HHb, and TSI, via the NIRS PortaMon device during the on-off kinetics protocol.

  From enrollment to the end of chemotherapy treatment, an average of 12 weeks

Secondary Outcomes (1)

• Whole body oxygen uptake via indirect calorimetry

  From enrollment to the end of chemotherapy treatment, an average of 12 weeks

Study Arms (1)

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

Females ages 20...

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study focuses on breast cancer or gynecological cancer patients who will undergo a standard of care chemotherapy treatment as directed by their oncologist.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead
• Furman University: collaborator
• Prisma Health-Upstate: collaborator

Study Sites (1)

Prisma Health Cancer Institute

Greenville, South Carolina, 29605, United States

RECRUITING

Related Publications (1)

• Hutchison RE, Smith S, Caudell C, Biddle S, Gluck WL, Trilk JL. Effects of chemotherapy on skeletal muscle mitochondrial oxidative capacity using near-infrared spectroscopy (NIRS): Protocol paper for an observational mixed model repeated measures design in patients with breast and gynecological cancer. PLoS One. 2025 Jun 27;20(6):e0315351. doi: 10.1371/journal.pone.0315351. eCollection 2025.

  PMID: 40577323 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jennifer L Trilk, PhD

  University of South Carolina School of Medicine, Greenville

  PRINCIPAL INVESTIGATOR

• Randolph Hutchison, PhD

  Furman University

  PRINCIPAL INVESTIGATOR

• Larry Gluck, MD

  Prisma Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer L Trilk, PhD

CONTACT

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

Frankie Bennett, MS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biomedical Sciences and Director of the Human Performance Lab

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: September 7, 2021
• Primary Completion: August 1, 2025
• Study Completion: March 1, 2026
• Last Updated: November 4, 2024

Record last verified: 2024-11

Locations

US (1)