Improving cancer-related fatigue, sexual dysfunction and quality of life in older men with cancer and androgen deficiency

改善患有癌症和雄激素缺乏的老年男性与癌症相关的疲劳、性功能障碍和生活质量

• 批准号: 9816135
• 负责人: Shehzad Basaria
• 金额: $ 70.85万
• 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: 2019-08-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9816135
• 关键词: Affect; Age; American; Androgens; Body Composition; Cancer Patient; Caregiver Burden; Caregivers; Clinical; Clinical Trials; Cranial Irradiation; Data; Decreased Libido; Diagnosis; Disease; Double-Blind Method; Elderly man; Erectile dysfunction; FDA approved; Fatigue; Functional disorder; Gel; Goals; Gonadotropins; High Prevalence; Hypogonadism; Incidence; Individual; Malignant Neoplasms; Malnutrition; Measurement; Measures; Moods; Morbidity - disease rate; Muscle function; Opioid Analgesics; Outcome; Participant; Patient Outcomes Assessments; Patients; Pelvis; Personal Satisfaction; Pharmaceutical Preparations; Phenotype; Physical Function; Physiological; Pilot Projects; Pituitary Gland; Placebos; Population; Prevalence; Provider; Quality of life; Radiation; Radiation therapy; Randomized; Randomized Controlled Trials; Reference Values; Reporting; Role; Serum; Sex Behavior; Sex Functioning; Sexual Dysfunction; Solid; Solid Neoplasm; Surveys; Symptoms; Testosterone; Therapeutic; Treatment-Related Cancer; United States; Well in self; aging population; cancer therapy; chemotherapy; comparative efficacy; disabling symptom; double-blind placebo controlled trial; effective therapy; experience; human old age (65+); improved; lean body mass; male; member; men; muscle strength; older men; older patient; patient population; population based; primary outcome; productivity loss; randomized placebo controlled trial; reduce symptoms; reduced muscle strength; symptom management; testosterone replacement therapy

PROJECT SUMMARY By the year 2050, the number of individuals in the United States over the age of 65 is expected to increase to over 80 million, comprising 20% of the population. The incidence of most common cancers increases with age and fatigue is one of the most prevalent and debilitating symptoms in patients with cancer, affecting 70-100% of patients, with the highest prevalence in elderly patients. The prevalence is even higher in patients receiving chemotherapy and/or radiation therapy. In spite of the significance of the burden, there are currently no FDA- approved treatments for cancer-related fatigue. In addition to fatigue, sexual dysfunction and decreased lean body mass are also highly prevalent in older men with cancer and contribute to decreased physical function and poor quality of life (QOL). This phenotype is commonly encountered in non-cancer older men with low serum testosterone levels. Testosterone deficiency is highly prevalent (50-90%) in older men with cancer. Clinical trials of testosterone replacement therapy in non-cancer older men have shown an improvement in well-being, QOL, 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. The overall goal of this proposal is to evaluate the efficacy of physiologic testosterone replacement therapy in improving fatigue and other outcomes such as sexual function, QOL, body composition, muscle strength and physical function in a double-blind, randomized, placebo-controlled trial in older men with incurable solid tumors who report fatigue and have low testosterone levels. We propose a large, 6-month trial in which we will compare the efficacy of physiologic testosterone replacement with a transdermal testosterone gel (the most convenient and widely used form of testosterone replacement) versus placebo gel in men age 60 and older with cancer who report fatigue and have testosterone deficiency. The following outcomes will be measured: 1) fatigue scores, 2) sexual function, well-being, mood and quality of life and caregiver burden, and 3) body composition, muscle strength and physical function. We will also perform qualitative surveys to explore lived experiences of the trial participants. With the growing recognition of the importance of symptom control in the lives of patients with cancer, including those undergoing cancer therapies, the proposed trial is highly relevant given that it is likely to have a significant impact on symptom management and quality of life in older men with cancer. If testosterone therapy is found to be efficacious in alleviating these symptoms, the clinicians will have available to them a therapeutic option that is inexpensive, convenient to use and relatively safe.

项目总结 到2050年，美国65岁以上的人口预计将增加到 超过8000万，占总人口的20%。大多数常见癌症的发病率随着年龄的增长而增加。 疲倦是癌症患者最普遍和最虚弱的症状之一，影响到70%-100% 老年患者中患病率最高。在接受治疗的患者中，患病率甚至更高 化疗和/或放射治疗。尽管负担重大，但目前没有FDA- 经批准的治疗癌症相关疲劳的方法。除了疲劳、性功能障碍和减少 瘦体重在患有癌症的老年男性中也非常普遍，并导致体能下降 功能和低生活质量(QOL)。这种表型常见于非癌症的老年男性。 血清睾丸素水平较低。睾丸素缺乏在老年男性中非常普遍(50%-90%) 癌症。在非癌症老年男性中进行的睾酮替代疗法的临床试验表明， 随机服用睾丸素的男性幸福感、生活质量、性功能和身体成分的改善 与安慰剂相比。然而，睾酮替代疗法对癌症相关疾病的疗效 疲劳还没有被研究过。这项建议的总体目标是评估生理学的疗效 睾酮替代疗法改善疲劳和性功能、生活质量、身体等结果 一项双盲、随机、安慰剂对照试验的成分、肌肉力量和身体功能 患有无法治愈的实体肿瘤的老年男性，他们报告说很疲惫，睾丸素水平较低。我们提出了一个 在为期6个月的大型试验中，我们将比较生理性睾丸素替代疗法和 透皮睾酮凝胶(最方便和最广泛使用的睾酮替代形式)与 安慰剂凝胶适用于60岁及以上患有癌症、报告疲劳和睾丸素缺乏的男性。这个 将测量以下结果：1)疲劳评分；2)性功能、幸福感、情绪和生活质量 和照顾者的负担，以及3)身体成分、肌肉力量和身体功能。我们还将表演 质的调查，以探索试验参与者的生活经验。随着人们越来越多地认识到 症状控制在癌症患者生活中的重要性，包括癌症患者 治疗，拟议的试验是高度相关的，因为它可能会对症状产生重大影响 癌症老年男性的管理和生活质量。如果睾丸素疗法被发现对 缓解这些症状，临床医生将为他们提供廉价的治疗选择， 使用方便，相对安全。