Hutchison Randolph Edward, Smith Shannon, Caudell Chloe, Biddle Sara, Gluck William Larry, Trilk Jennifer L
Department of Health Sciences, Furman University, Greenville, South Carolina, United States of America.
Department of Biomedical Sciences, University of South Carolina School of Medicine Greenville, Greenville, South Carolina, United States of America.
PLoS One. 2025 Jun 27;20(6):e0315351. doi: 10.1371/journal.pone.0315351. eCollection 2025.
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.
线粒体功能障碍是骨骼肌代谢紊乱的一个标志，此前在健康参与者中使用侵入性肌肉活检和/或耗时、高成本的磁共振波谱进行过研究。然而，对于癌症患者的线粒体功能障碍了解较少。近红外光谱（NIRS）是一种通过测量氧合血红蛋白和脱氧血红蛋白并计算所得组织饱和度指数来评估骨骼肌线粒体功能的非侵入性且经济高效的方法。NIRS尚未被用于评估癌症患者在整个化疗过程中的骨骼肌变化。因此，我们计划开展一项单中心临床试验，采用观察性混合模型重复测量设计，以评估从基线开始以及在肿瘤学家规定的化疗方案进展过程中线粒体氧化能力的变化。线粒体功能评估将通过在静态自行车运动及随后的恢复期间（例如“运动中（on）”动力学和“运动后（off）”动力学）对工作肌肉进行实时、原位NIRS测量来进行。我们还计划观察不同患者的不同化疗方案之间线粒体氧化能力是否存在差异。这项初步研究将提供有关在新诊断的乳腺癌或妇科癌症患者中使用NIRS纵向获取运动中/运动后线粒体功能数据的可行性信息，为未来的外部资金提供初步数据，并通过会议和同行评审期刊出版物传播结果，将研究结果告知科学界。该临床试验已在clinicaltrials.gov上注册（标识符：NCT006672497）。数据收集于2021年7月26日开始，目前正在进行，直至2026年3月27日。作者确认该观察性试验（无药物或干预）的所有正在进行的及相关试验均已注册。
