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。虽然现象的 体重增加是一致的，在接受治疗的患者中， 多药剂、高剂量方案和年轻人（25%的 绝经前患者在治疗期间增加超过11 kg）。患者报告 体重增加是“令人痛苦的”也有证据表明，体重增加不利 影响无病生存率，并使妇女易患心血管疾病 和糖尿病化疗引起的体重增加也是不同的-患者失去 肌肉，因为他们获得脂肪组织，从而呼吁干预，促进 锻炼的在一项初步研究中，我们发现，肌肉的损失和肌肉的增加， 如果患者参加基于诊所的计划， 提倡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 由于旅行的障碍而参加。由于许多癌症患者长途旅行 距离接受护理，此R21应用程序的目的是确定 基于家庭的锻炼干预是否可行， 合作团体（合作社区肿瘤学计划（CCOP））和显示 承诺在更大的群体环境中进行进一步的测试，如癌症和 白血病B组（CALGB）。 我们已经调整了我们的计划，这是基于国家的最先进的健身 设施，以便携式健身器材，并制定了配套材料 (i.e.,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， 美国确定是否以家庭为基础的锻炼计划承担承诺， 使用合作社的基础设施进行实施和测试是可行的 组我们提出了一项研究，将衡量的影响，一个运动单独或 运动加饮食干预对预防体重增加和不良变化 在身体成分，减少抑郁症，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）。我们建议进行一项试点研究， 将在90年的基线和诊断后6个月评估终点 将接受辅助治疗的绝经前早期乳腺癌患者 化疗，并被区组随机分为3个研究组之一（注意 对照、单独锻炼或锻炼加饮食）。如果数据显示有希望， 将进行更大规模的研究-这项研究将侧重于测试 最佳干预和功率已知的效果大小。