Clinical trial · Observational
Near Infrared Spectroscopy (NIRS) as a Method for Measuring Oxidative Capacity of Skeletal Muscle Mitochondria in Breast Cancer and All Gynecological Cancer Patients
NCT06672497CI-TRIAL-00082175recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Gynecologic Cancers | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Mitochondrial Function | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients diagnosed with breast or gynecological cancer and undergoing neoadjuvant chemotherapy.
- description
- Females ages 20...
Primary outcomes (1)
- measure
- Muscle mitochondrial oxidative capacity
- timeFrame
- From enrollment to the end of chemotherapy treatment, an average of 12 weeks
- description
- Study staff will measure O2Hb, HHb, and TSI, via the NIRS PortaMon device during the on-off kinetics protocol.
Secondary outcomes (1)
- measure
- Whole body oxygen uptake via indirect calorimetry
- timeFrame
- From enrollment to the end of chemotherapy treatment, an average of 12 weeks
- description
- We also will measure ventilatory whole-body components including O2 and CO2 via the Parvomedics metabolic cart.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHutchison 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