STRENGTH--Survivor TRaining for ENhancinG Total Health

力量——增强整体健康的幸存者培训

• 批准号: 6515207
• 负责人: WENDY DEMARK-WAHNEFRIED
• 金额: $ 15.4万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-07-15 至 2005-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6515207
• 关键词: body composition; breast neoplasms; clinical research; depression; diet therapy; exercise; hormone binding protein; hormone regulation /control mechanism; human subject; human therapy evaluation; insulin; insulinlike growth factor; neoplasm /cancer therapy; nutrition aspect of cancer; nutrition related tag; psychological aspect of cancer; quality of life

DESCRIPTION (provided by applicant): Weight gain is a common side effect that accompanies adjuvant chemotherapy for breast cancer. While the phenomenon of weight gain is consistent, the magnitude is greater among patients who receive multi-agent, high dose regimens and among those who are younger (25 percent of premenopausal patients gain over 11 kg during treatment). Patients report weight gain as "distressing" There also is evidence that weight gain adversely affects disease-free survival, and predisposes women to cardiovascular disease and diabetes. Chemotherapy-induced weight gain also is distinct - patients lose muscle as they gain adipose tissue, thus calling for interventions that promote exercise. In a preliminary study, we found that losses in muscle and gains in fat can be prevented if patients participate in a clinic-based program that promotes specific exercises and a low fat, high vegetable and fruit diet during the time they receive treatment. While these data are encouraging, few patients participated due to barriers of travel. Since many cancer patients travel long distances to receive care, the purpose of this R21 application is to ascertain whether home-based exercise interventions are feasible using the framework of the cooperative group (Cooperative Community Oncology Program (CCOP)) and show promise for further testing in a larger group setting, such as the Cancer and Leukemia Group B (CALGB). We have adapted our program that was based in a state-of-the-art fitness facility to portable gym equipment, and have developed accompanying materials (i.e., videotapes and manuals), as well as a program of telephone counseling. We also have obtained the support of the Wake Forest Research Base CCOP to help us ascertain whether a home-based exercise program bears promise and is feasible to implement and test using the infrastructure of the cooperative group. We propose a study that will measure the effects of an exercise alone or exercise plus diet intervention on preventing weight gain and adverse changes in body composition, reducing depression, improving quality of life and influencing biomarkers associated with breast cancer and other co-morbid conditions (i.e., insulin, insulin-like growth factor-i, sex hormone binding globulin and lipoprotein profiles). We propose a pilot study where these endpoints will be assessed at baseline and 6 months post-diagnosis in 90 premenopausal early stage breast cancer patients who will receive adjuvant chemotherapy and are block randomized into 1 of 3 study arms (attention control, exercise alone or exercise plus diet). If data show promise, further and larger study will be pursued - study which will be focused on testing an optimal intervention and powered on known effect sizes.

描述（由申请人提供）：体重增加是一种常见的副作用， 伴随乳腺癌的辅助化疗。虽然现象 体重增加是一致的，接受治疗的患者体重增加幅度更大 多药、高剂量治疗方案以及年轻人群（25% 绝经前患者在治疗期间体重增加超过 11 公斤）。患者报告 体重增加“令人痛苦” 还有证据表明体重增加会产生不利影响 影响无病生存，并使女性易患心血管疾病 和糖尿病。化疗引起的体重增加也很明显——患者体重减轻 当他们获得脂肪组织时会增加肌肉，因此需要采取干预措施来促进 锻炼。在一项初步研究中，我们发现肌肉的损失和肌肉的增加 如果患者参加基于临床的计划，则可以预防肥胖 促进特定的锻炼和低脂肪、高蔬菜和水果饮食 他们接受治疗的时间。虽然这些数据令人鼓舞，但很少有患者 由于旅行障碍参加。由于许多癌症患者长途旅行 接受护理的距离，此 R21 申请的目的是确定 使用以下框架进行家庭运动干预是否可行 合作小组（合作社区肿瘤学计划（CCOP））并展示 承诺在更大的群体环境中进行进一步测试，例如癌症和 B 类白血病 (CALGB)。 我们调整了基于最先进健身的计划 设施到便携式健身器材，并开发了配套材料 （即录像带和手册）以及电话咨询计划。 我们还获得了维克森林研究基地CCOP的支持来帮助 我们确定家庭锻炼计划是否有希望并且可行 使用合作社的基础设施实施和测试是可行的 团体。我们提出了一项研究来衡量单独锻炼或锻炼的效果 运动加饮食干预预防体重增加和不良变化 身体成分，减少抑郁，提高生活质量 影响与乳腺癌和其他共病相关的生物标志物 条件（即胰岛素、胰岛素样生长因子-i、性激素结合 球蛋白和脂蛋白谱）。我们提出一项试点研究，其中这些 终点将在基线和诊断后 6 个月进行评估 90 将接受辅助治疗的绝经前早期乳腺癌患者 化疗并被随机分为 3 个研究组中的 1 个（注意 控制，单独运动或运动加饮食）。如果数据显示出希望，进一步 并且将进行更大规模的研究——研究的重点是测试 最佳干预并以已知的效应大小为动力。