Inclusion and exclusion criteria.

Mitochondrial dysfunction, a hallmark of metabolic disturbances in the skeletal muscle, has previously been studied in health participants using invasive muscle biopsy and/or time consuming, high-cost magnetic resonance spectroscopy. However, less is understood regarding mitochondrial dysfunction in patients with cancer. Near infrared spectroscopy (NIRS) is a non-invasive and cost-effective approach to assessing mitochondrial function of skeletal muscle by measuring oxygenated and deoxygenated hemoglobin and calculating the resulting tissue saturation index. NIRS has not yet been utilized to evaluate skeletal muscle change in cancer patients throughout chemotherapy. Therefore, we plan to conduct a single center clinical trial, using an observational mixed model repeated measures design to evaluate the change in mitochondrial oxidative capacity from baseline and throughout progression of an oncologist-prescribed chemotherapy regimen. Evaluation of mitochondrial function will be performed by taking real-time, NIRS in-situ measurements within the working muscle during stationary cycling exercise and subsequent recovery periods (e.g., “on” kinetics and “off” kinetics). We also plan to observe if there is a difference in mitochondrial oxidative capacity between different chemotherapy regimens across different patients. This pilot study will provide information on the feasibility of capturing on/off kinetics mitochondrial function data longitudinally using NIRS in patients newly diagnosed with breast or gynecological cancer, provide preliminary data for future extramural funding, as well as inform the scientific community of results through dissemination via conferences and peer-reviewed journal publications.
This clinical trial has been registered with clinicaltrials.gov (Identifier: NCT006672497). Data collection started on July 26, 2021 and is ongoing through March 27, 2026. The authors confirm that all ongoing and related trials for this observation trial (no drug or intervention) are registered.