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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20+
SponsorUniversity of South Carolina

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Metastatic breast or gynecological cancer

Clinically advanced cardiovascular disease

Clinically advanced pulmonary disease

Disease requiring continuous oxygen supplementation

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 1 trial group
Group A: Patients diagnosed with breast or gynecological cancer and undergoing neoadjuvant chemotherapy.

Trial outcomes

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.

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

Secondary outcomes

1

Whole body oxygen uptake via indirect calorimetry

We also will measure ventilatory whole-body components including O2 and CO2 via the Parvomedics metabolic cart.

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

Other outcomes

Sponsors and contacts

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University of South Carolina

Lead sponsor

Furman University

Collaborator

Prisma Health-Upstate

Collaborator