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 该提案的总体目标是评估睾丸激素替代疗法改善的疗效 疲劳和其他结果，例如性功能，生活质量，身体成分，肌肉力量和 举报的年轻癌症幸存者的双盲，随机，安慰剂对照试验的体育锻炼 疲劳和睾丸激素缺乏症。疲劳是最普遍，令人衰弱的症状之一 患有癌症的男性影响70-100％的患者，无论其年龄如何。与癌症有关的疲劳经历了 患者不仅在活跃的癌症治疗期间，而且在表现出的癌症幸存者中也很普遍 治疗结束后的几个月至数年，患病率最高 化学疗法和/或放射疗法的接受者。除疲劳外，性功能障碍也是 在男性癌症幸存者中高度普遍。男性癌症幸存者还增加了脂肪质量，并且 减少了瘦体重，这种表型使它们容易降低肌肉力量。这个表型 非癌症患者通常会遇到性功能障碍和不良身体组成 睾丸激素缺乏症的种群，这种疾病在癌症中也很普遍（50-90％） 幸存者。非癌症患者人群中睾丸激素替代疗法的关键试验显示 比较随机分配睾丸激素的男性的疲劳，性功能和身体成分的改善 安慰剂。但是，睾丸激素替代疗法对癌症相关疲劳的功效尚未 被研究。我们提出了一个大型，9个月的双盲，随机，安慰剂对照试验，其中：1）我们 将比较每周睾丸激素注射的功效与安慰剂在改善癌症的疲劳评分方面的功效 报告疲劳并患有睾丸激素缺乏症的幸存者，2）我们将比较 睾丸激素替代与安慰剂在性功能，幸福感，情绪和生活质量方面，以及3）我们 将确定睾丸激素给药对身体成分，肌肉力量和物理的影响 与安慰剂相比。随着癌症幸存者的寿命和增长的增长 认识到症状控制在这些患者生活中的重要性，拟议的试验很可能 对患者报告结果的管理有重大临床影响。如果睾丸激素治疗是 临床医生将有效地减轻这些症状，可以为他们提供治疗 相对便宜，使用方便的选择，在年轻人中具有良好的安全记录。