Department of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, 77555, USA.
Department of Gynecologic Oncology, The University of Texas Medical Branch, Galveston, TX, 77555, USA.
J Cachexia Sarcopenia Muscle. 2018 Jun;9(3):482-496. doi: 10.1002/jcsm.12295. Epub 2018 Apr 14.
Cancer cachexia negatively impacts cancer-related treatment options, quality of life, morbidity, and mortality, yet no established therapies exist. We investigated the anabolic properties of testosterone to limit the loss of body mass in late stage cancer patients undergoing standard of care cancer treatment.
A randomized, double-blind, placebo-controlled phase II clinical trial was undertaken to assess the potential therapeutic role of adjunct testosterone to limit loss of body mass in patients with squamous cell carcinoma of the cervix or head and neck undergoing standard of care treatment including chemotherapy and chemoradiation. Patients were randomly assigned in blocks to receive weekly injections of either 100 mg testosterone enanthate or placebo for 7 weeks. The primary outcome was per cent change in lean body mass, and secondary outcomes included assessment of quality of life, tests of physical performance, muscle strength, daily activity levels, resting energy expenditure, nutritional intake, and overall survival.
A total of 28 patients were enrolled, 22 patients were studied to completion, and 21 patients were included in the final analysis (12 placebo, nine testosterone). Adjunct testosterone increased lean body mass by 3.2% (95% confidence interval [CI], 0-7%) whereas those receiving placebo lost 3.3% (95% CI, -7% to 1%, P = 0.015). Although testosterone patients maintained more favourable body condition, sustained daily activity levels, and showed meaningful improvements in quality of life and physical performance, overall survival was similar in both treatment groups.
In patients with advanced cancer undergoing the early phase of standard of care therapy, adjunct testosterone improved lean body mass and was also associated with increased quality of life, and physical activity compared with placebo.
癌症恶病质会对癌症相关的治疗选择、生活质量、发病率和死亡率产生负面影响，但目前尚无既定的治疗方法。我们研究了睾丸酮的合成代谢特性，以限制正在接受标准癌症治疗的晚期癌症患者的体重减轻。
进行了一项随机、双盲、安慰剂对照的 II 期临床试验，以评估辅助睾丸酮治疗对接受标准治疗（包括化疗和放化疗）的宫颈癌或头颈部鳞状细胞癌患者限制体重减轻的潜在治疗作用。患者按块随机分配每周接受 100mg 庚酸睾丸酮或安慰剂注射，共 7 周。主要结局是瘦体重的百分比变化，次要结局包括生活质量评估、身体机能测试、肌肉力量、日常活动水平、静息能量消耗、营养摄入和总生存。
共纳入 28 例患者，22 例完成研究，21 例患者纳入最终分析（安慰剂 12 例，睾丸酮 9 例）。辅助睾丸酮使瘦体重增加 3.2%（95%置信区间，0-7%），而接受安慰剂的患者则减少 3.3%（95%置信区间，-7%至 1%，P=0.015）。尽管睾丸酮组患者保持了更好的身体状况、持续的日常活动水平，并在生活质量和身体机能方面有了显著改善，但两组患者的总生存率相似。
在接受标准治疗早期阶段的晚期癌症患者中，辅助睾丸酮可增加瘦体重，并与安慰剂相比提高生活质量和身体活动能力。
