Department of Internal Medicine, The University of Texas Medical Branch (UTMB), 301 University Blvd., Galveston, TX 77555, USA.
Curr Oncol. 2022 Nov 1;29(11):8340-8356. doi: 10.3390/curroncol29110658.
Many cancer patients undergoing treatment experience cancer-related fatigue (CRF). Inflammatory markers are correlated with CRF but are not routinely targeted for treatment. We previously demonstrated in an NIH-funded placebo-controlled, double-blind, randomized clinical trial (NCT00878995, closed to follow-up) that seven weekly injections of 100 mg adjunct testosterone preserved lean body mass in cancer patients undergoing standard-of-care treatment in a hospital setting. Because testosterone therapy can reduce circulating proinflammatory cytokines, we conducted an ancillary analysis to determine if this testosterone treatment reduced inflammatory burden and improved CRF symptoms and health-related quality of life. Randomization was computer-generated and managed by the pharmacy, which dispensed testosterone and placebo in opaque syringes to the administering study personnel. A total of 24 patients were randomized (14 placebo, 10 testosterone), and 21 were included in the primary analysis (11 placebo, 10 testosterone). Testosterone therapy did not ameliorate CRF symptoms (placebo to testosterone difference in predicted mean multidimensional fatigue symptom inventory scores: -5.6, 95% CI: -24.6 to 13.3), improve inflammatory markers, or preserve health-related quality of life and functional measures of performance in late-stage cancer patients.
许多正在接受治疗的癌症患者会经历癌症相关性乏力（CRF）。炎症标志物与 CRF 相关，但并未常规针对其进行治疗。我们之前在一项由美国国立卫生研究院（NIH）资助的安慰剂对照、双盲、随机临床试验（NCT00878995，随访结束）中证明，每周接受 100mg 辅助睾酮治疗 7 次，可以在医院环境中接受标准治疗的癌症患者中保留瘦体重。由于睾酮治疗可以降低循环中的促炎细胞因子，我们进行了一项辅助分析，以确定这种睾酮治疗是否可以减轻炎症负担并改善 CRF 症状和健康相关的生活质量。随机化是由计算机生成的，并由药房管理，药房将睾酮和安慰剂装在不透明的注射器中分发给进行研究的医务人员。共有 24 名患者被随机分配（14 名安慰剂，10 名睾酮），21 名患者被纳入主要分析（11 名安慰剂，10 名睾酮）。睾酮治疗并未改善 CRF 症状（安慰剂到睾酮的预测平均多维疲劳症状清单评分差异：-5.6，95%CI：-24.6 至 13.3），也未改善炎症标志物，或保留健康相关的生活质量和晚期癌症患者的身体机能测量指标。
