Improving Patient-Important Outcomes with Testosterone Replacement in Hypogonadal Men with a Prior History of Cancer

通过睾酮替代疗法改善有癌症病史的性腺功能减退男性的患者重要结果

• 批准号: 10223238
• 负责人: Shehzad Basaria
• 金额: $ 64.36万
• 依托单位: SEATTLE INST FOR BIOMEDICAL/CLINICAL RES
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-08 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10223238
• 关键词: Affect; Age; Body Composition; Cancer Patient; Cancer Survivor; Cardiovascular system; Chemotherapy and/or radiation; Clinic; Clinical; Cranial Irradiation; Data; Decreased Libido; Diagnosis; Disease remission; Double-Blind Method; Erectile dysfunction; Exhibits; Fatigue; Fatty acid glycerol esters; Goals; High Prevalence; Individual; Injections; Longevity; Malignant Neoplasms; Measurement; Moods; Outcome; Patient Outcomes Assessments; Patients; Pelvis; Personal Satisfaction; Phenotype; Physical activity; Pilot Projects; Pituitary Gland; Placebo Control; Placebos; Prevalence; Prior Chemotherapy; Productivity; Prostate; Quality of life; Radiation therapy; Randomized; Randomized Controlled Trials; Recording of previous events; Reference Values; Reporting; Research; Role; Safety; Sex Behavior; Sex Functioning; Sexual Dysfunction; Supervision; Symptoms; Testosterone; Therapeutic; United States; active method; cancer therapy; chemotherapy; comparative efficacy; disabling symptom; double-blind placebo controlled trial; efficacy evaluation; experience; improved; lean body mass; male; member; men; muscle strength; older men; patient population; population based; primary outcome; randomized placebo controlled trial; reduce symptoms; reduced muscle strength; side effect; testosterone replacement therapy; young cancer survivor; young man

PROJECT SUMMARY/ABSTRACT The overall goal of this proposal is to evaluate the efficacy of testosterone replacement therapy in improving fatigue and other outcomes such as sexual function, quality of life, body composition, muscle strength and physical activity in a double-blind, randomized, placebo-controlled trial in young cancer survivors who report fatigue and have testosterone deficiency. Fatigue is one of the most prevalent and debilitating symptoms in men with cancer affecting 70-100% of patients irrespective of their age. Cancer-related fatigue is experienced by patients not only during active cancer treatment, but is also highly prevalent in cancer survivors who exhibit persistent fatigue months to years after the end of their treatment with the highest prevalence being in recipients of chemotherapy and/or radiation therapy. In addition to fatigue, sexual dysfunction is also highly prevalent in male cancer survivors. Male cancer survivors also have increased fat mass and decreased lean body mass, a phenotype that predisposes them to reduced muscle strength. This phenotype of fatigue, sexual dysfunction and adverse body composition is commonly encountered in non-cancer patient populations with testosterone deficiency, a condition which is also highly prevalent (50-90%) in cancer survivors. Pivotal trials of testosterone replacement therapy in non-cancer patient populations have shown an improvement in fatigue, sexual function and body composition in men randomized to testosterone compared with placebo. However, the efficacy of testosterone replacement therapy on cancer-related fatigue has not been studied. We propose a large, 9-month, double-blind, randomized, placebo-controlled trial in which: 1) we will compare the efficacy of weekly testosterone injections versus placebo in improving fatigue scores in cancer survivors who report fatigue and also have testosterone deficiency, 2) we will compare the effects of testosterone replacement versus placebo on sexual function, well-being, mood and quality of life, and 3) we will determine the effect of testosterone administration on body composition, muscle strength and physical activity compared with placebo. With an increase in longevity among cancer survivors and the growing recognition of the importance of symptom control in the lives of these patients, the proposed trial is likely to have a significant clinical impact in the management of patient-reported outcomes. If testosterone therapy is found to be efficacious in alleviating these symptoms, the clinicians will have available to them a therapeutic option that is relatively inexpensive, convenient to use and has a good safety record in young men.

项目摘要/摘要 这项建议的总体目标是评估睾酮替代疗法在改善 疲劳和其他结果，如性功能、生活质量、身体成分、肌肉力量和 在一项双盲、随机、安慰剂对照的年轻癌症幸存者试验中进行体力活动 疲劳，并有睾丸素缺乏。疲劳是最普遍和最令人虚弱的症状之一 男性癌症患者的比例为70%-100%，无论他们的年龄如何。与癌症相关的疲劳是有经验的 患者不仅在积极的癌症治疗期间，而且在癌症幸存者中也非常普遍，他们表现出 在治疗结束后数月至数年持续疲倦，患病率最高的是 化疗和/或放射治疗的接受者。除了疲劳，性功能障碍也是 在男性癌症幸存者中非常普遍。男性癌症幸存者的脂肪质量也增加了， 瘦体重下降，这是一种易导致肌肉力量下降的表型。这种表型 乏力、性功能障碍和身体成分不良在非癌症患者中常见 患有睾丸素缺乏的人群，这种情况在癌症中也很常见(50%-90%) 幸存者。在非癌症患者人群中进行的睾酮替代疗法的关键试验表明， 随机服用睾丸素的男性在疲劳、性功能和身体成分方面的改善 用安慰剂。然而，睾酮替代疗法对癌症相关性疲劳的疗效并不明显。 已经研究过了。我们提出了一项为期9个月的大型双盲、随机、安慰剂对照试验：1)我们 将比较每周注射睾丸素和安慰剂改善癌症患者疲劳评分的效果 报告疲劳和睾丸素缺乏的幸存者，2)我们将比较 睾丸素替代与安慰剂对性功能、幸福感、情绪和生活质量的影响，以及3)我们 将决定服用睾丸素对身体成分、肌肉力量和体能的影响 活动量与安慰剂相比。随着癌症幸存者寿命的延长和不断增长的 认识到症状控制在这些患者生活中的重要性，拟议的试验可能会 在管理患者报告的结果方面有重大的临床影响。如果睾丸素疗法是 被发现对缓解这些症状有效，临床医生将有治疗方法 这种选择相对便宜，使用方便，在年轻男性中有良好的安全记录。