University of Texas M D Anderson Cancer Center, Department of Palliative Care and Rehabilitation Medicine, Houston, TX, USA.
Support Care Cancer. 2013 Sep;21(9):2599-607. doi: 10.1007/s00520-013-1832-5. Epub 2013 May 8.
Uncontrolled studies show fatigue, anorexia, depression, and mortality are associated with low testosterone in men with cancer. Testosterone replacement improves quality of life and diminishes fatigue in patients with non-cancer conditions. The primary objective was to evaluate the effect of testosterone replacement on fatigue in hypogonadal males with advanced cancer, by the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-Fatigue) at day 29.
This is a randomized, double-blinded placebo-controlled trial. Outpatients with advanced cancer, bioavailable testosterone (BT) <70 ng/dL and fatigue score >3/10 on the Edmonton Symptom Assessment Scale were eligible. Intra-muscular testosterone or sesame seed oil placebo was administered every 14 days to achieve BT levels 70-270 ng/dL.
Sixteen placebo and 13 testosterone-treated subjects were evaluable. No statistically significant difference was found for FACIT-fatigue scores between arms (-2 ± 12 for placebo, 4 ± 8 for testosterone, p = 0.11). Sexual Desire Inventory score (p = 0.054) and performance status (p = 0.02) improved in the testosterone group. Fatigue subscale scores were significantly better (p = 0.03) in those treated with testosterone by day 72.
Four weeks of intramuscular testosterone replacement in hypogonadal male patients with advanced cancer did not significantly improve quality of life. Larger studies of longer duration are warranted.
非控制性研究表明，癌症男性的睾丸酮水平低与疲劳、厌食、抑郁和死亡率有关。睾丸酮替代治疗可改善非癌症患者的生活质量并减轻疲劳。主要目的是通过慢性疾病治疗功能评估-疲劳量表（FACIT-Fatigue）在第 29 天评估睾丸酮替代治疗对晚期癌症低睾丸酮男性疲劳的影响。
这是一项随机、双盲、安慰剂对照试验。符合条件的是患有晚期癌症、生物可利用睾丸酮（BT）<70ng/dL 和疲劳评分> Edmonton 症状评估量表上的 10/3。每隔 14 天肌肉内注射睾丸酮或芝麻籽油安慰剂，使 BT 水平达到 70-270ng/dL。
16 名安慰剂和 13 名睾丸酮治疗的受试者可评估。手臂之间的 FACIT-Fatigue 评分无统计学差异（安慰剂为-2±12，睾丸酮为 4±8，p=0.11）。睾丸酮组的性欲量表评分（p=0.054）和表现状态（p=0.02）改善。第 72 天，接受睾丸酮治疗的患者疲劳量表评分显著更好（p=0.03）。
在患有晚期癌症的低睾丸酮男性患者中，肌肉内注射睾丸酮替代治疗 4 周并未显著改善生活质量。需要进行更长时间的更大规模研究。
