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

项目摘要 到2050年，美国65岁以上的人口预计将增加到 8000多万人，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 疲劳是癌症患者中最普遍和使人衰弱的症状之一，影响70-100%的癌症患者。 患者中，老年患者的患病率最高。在接受化疗的患者中， 化疗和/或放疗。尽管负担很重，但目前没有FDA- 治疗癌症相关疲劳的药物除了疲劳，性功能障碍和减少 瘦体重在患有癌症老年男性中也非常普遍， 功能和生活质量（QOL）差。这种表型常见于非癌症老年男性 血清睾酮水平低睾酮缺乏症在老年男性中非常普遍（50-90%）， 癌在非癌症老年男性中进行的睾酮替代疗法的临床试验显示， 随机接受睾酮治疗男性的幸福感、生活质量、性功能和身体成分改善 与安慰剂相比。然而，睾酮替代疗法对癌症相关性 疲劳还没有被研究过。本提案的总体目标是评估生理性 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 在一项双盲、随机、安慰剂对照试验中， 患有无法治愈的实体瘤的老年男性，他们报告疲劳和睾丸激素水平低。我们提出了一个 一项为期6个月的大型试验，我们将比较生理性睾酮替代疗法与 经皮睾酮凝胶（最方便和最广泛使用的睾酮替代形式）与 安慰剂凝胶用于报告疲劳和睾酮缺乏的60岁及以上癌症患者。的 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 和照顾者负担，和3）身体组成，肌肉力量和身体功能。我们还将表演 定性调查，以探索试验参与者的生活经历。随着人们越来越认识到 症状控制在癌症患者生活中的重要性，包括那些正在接受癌症治疗的患者 治疗，拟议的试验是高度相关的，因为它可能对症状有显着影响， 老年男性癌症患者的治疗和生活质量。如果发现睾酮治疗对 减轻这些症状，临床医生将有一种便宜的治疗选择， 使用方便且相对安全。

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.