BIOPSYCHOSOCIAL BENEFITS OF 17 BETA ESTRADIOL IN METASTATIC CAP

17 β 雌二醇对转移帽的生物心理社会益处

• 批准号: 6501869
• 负责人: BERNARD A ROOS
• 金额: $ 20.68万
• 依托单位: UNIVERSITY OF MIAMI CORAL GABLES
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-01 至 2002-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6501869
• 关键词: behavioral /social science research tag; cancer rehabilitation /care; clinical research; estradiol; hormone therapy; human subject; human therapy evaluation; male; medical rehabilitation related tag; neoplasm /cancer palliative treatment; prostate neoplasms; psychological aspect of cancer; psychosocial rehabilitation; quality of life

Men diagnosed with advanced prostate cancer have a median survival of about 30 months, with many patients surviving as along as 5 to 10 years. This relatively slow progression of advanced disease distinguishes prostate cancer from other common malignancies and creates a situation in which men age in the context of premature and severe male hormone deprivation due to adjuvant therapies. This hormone deprivation may well hasten mental and physical deterioration and lower the quality of life in a number of spheres. Since testosterone can be converted to estrogen, certain physical and mental effects of testosterone could reflect its peripheral conversion (via aromatase) to estradiol. Conversely, some of the negative effects of testosterone deprivation by LHRH agonists or therapeutic castration could be due to lowered levels of estradiol. Moreover, clinical and animal studies suggest psychosocial and physical health benefits from estrogen in males. It's reduction in prostate cancer patients, therefore, could contribute to their morbidity. We propose a prospective, blinded clinical trial of low-dose estradiol to test our major hypothesis that chronic, low dose oral 17-beta estradiol therapy will preserve the overall quality of life and mental, emotional, and physical health status of men maintained on treatment-related androgen deprivation. We will enroll 150 cognitively intact (Mini-Mental Status Exam score >23) metastatic prostate patients into a double-blind, placebo controlled prospective study of low-dose estrogen (17-beta micronized estradiol 0.5 mg per day) for one year. We will measure various aspects of quality of life and physical, mental, and social functioning at 10 weeks (T2), 6 months (T3) and 12 months (T4) after study entry.

被诊断为晚期前列腺癌的男性的平均生存期约为30个月，许多患者的生存期长达5至10年。前列腺癌与其他常见恶性肿瘤的区别在于，晚期疾病进展相对缓慢，并造成男性在辅助治疗导致的过早和严重男性激素剥夺的情况下衰老。这种激素的缺乏很可能会加速精神和身体的恶化，并降低许多领域的生活质量。由于睾酮可以转化为雌激素，睾酮的某些生理和心理效应可以反映其外周转化（通过芳香化酶）为雌二醇。相反，LHRH激动剂或治疗性阉割的睾酮剥夺的一些负面影响可能是由于雌二醇水平降低。此外，临床和动物研究表明，雌性激素对男性的心理社会和身体健康有益。因此，前列腺癌患者的减少可能会导致他们的发病率。我们提出了一项低剂量雌二醇的前瞻性盲法临床试验，以验证我们的主要假设，即慢性，低剂量口服17- β雌二醇治疗将保持治疗相关雄激素剥夺的男性的整体生活质量和精神，情绪和身体健康状态。我们将招募150名认知功能完好（Mini-Mental Status Exam得分为bbb23）的转移性前列腺患者参加一项双盲、安慰剂对照的前瞻性研究，该研究使用低剂量雌激素（17- β微化雌二醇0.5 mg /天），为期一年。我们将在研究开始后的10周（T2）、6个月（T3）和12个月（T4）测量生活质量、身体、心理和社会功能的各个方面。