A Randomized Placebo Controlled Trial to Evaluate the Efficacy of Three Month Therapy of Ubidecarenone in Patients with Cisplatin Based Regimen Induced Cachexia

Cachexia is a multifactorial syndrome characterized by negative protein and energy balance, causing muscle loss and functional decline. Chemotherapy-induced cachexia results from mitochondrial ROS generation and mitochondrial dysfunction caused by chemotherapy. Ubidecarenone (Coenzyme Q), with its antioxidant properties, may mitigate these ill effects, though its efficacy in reducing severity of chemotherapy-induced cachexia remains unexplored. This study aimed to evaluate the efficacy of three month therapy of Ubidecarenone in patients with cisplatin based regimen induced cachexia at a tertiary care hospital in Aligarh, India. This double-blind, randomized, placebo-controlled prospective pilot study enrolled 60 patients, divided into two treatment arms: one receiving 100 mg Ubidecarenone and the other, matching placebo tablets. Over three months, patients were evaluated based on physical, hematological, biochemical, and inflammatory markers, with the CASCO score assessing chemotherapy-induced cachexia severity. There was no statistically significant difference observed between the BMI, body weight, body fat percentage, lean body mass, laboratory markers (CRP, ALC, haemoglobin, Leptin, and GDF-15) and the CASCO Score comparing the Ubidecarenone and Placebo arms. Ubidecarenone, although a promising candidate in reducing severity of chemotherapy-induced cachexia, demonstrated no significant efficacy in our study.
Keywords: Cachexia, Cancer, Chemotherapy, Coenzyme Q, Cisplatin, Ubidecarenone.

恶病质是一种多因素综合征，其特征为蛋白质和能量平衡的负性，导致肌肉萎缩和功能衰退。化疗诱导的恶病质源于化疗引起的线粒体活性氧生成和线粒体功能障碍。辅酶Q10（又称泛醌），凭借其抗氧化特性，可能减轻这些不良影响，尽管其在减轻化疗诱导的恶病质严重程度方面的疗效尚未得到充分探索。本研究旨在评估在印度阿利加尔的一家三级护理医院中，使用辅酶Q10三个月疗法治疗顺铂方案诱导的恶病质患者的疗效。这是一项双盲、随机、安慰剂对照的前瞻性试点研究，招募了60名患者，分为两组治疗：一组接受100毫克辅酶Q10，另一组接受匹配的安慰剂片剂。在三个月期间，患者根据生理、血液学、生化标志物和炎症标志物进行评估，CASCO评分用于评估化疗诱导的恶病质严重程度。在比较辅酶Q10组和安慰剂组的BMI、体重、体脂百分比、瘦体重、实验室标志物（C反应蛋白、碱性磷酸酶、血红蛋白、瘦素和GDF-15）以及CASCO评分时，未观察到统计学上的显著差异。尽管辅酶Q10在减轻化疗诱导的恶病质严重程度方面具有潜力，但本研究中并未显示出显著的疗效。关键词：恶病质、癌症、化疗、辅酶Q10、顺铂、泛醌。