STRENGTH--Survivor TRaining for ENhancinG Total Health

描述(申请人提供)：体重增加是一种常见的副作用， 伴随着乳腺癌的辅助化疗。而这一现象 体重增加是一致的，接受治疗的患者体重增加幅度更大 多剂、高剂量方案和年轻人群(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“苦恼”也有证据表明体重增加对身体有害 影响无病生存，并使女性易患心血管疾病 还有糖尿病。化疗导致的体重增加也很明显--患者体重减轻 肌肉随着脂肪组织的增加而增加，因此需要采取干预措施来促进 锻炼身体。在一项初步研究中，我们发现肌肉的损失和增加 如果患者参与以临床为基础的计划，那么肥胖是可以预防的 促进特定的运动和低脂肪、高蔬菜和水果的饮食 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，参加了会议。由于许多癌症患者需要长途跋涉 接受护理的距离，此R21应用程序的目的是确定 使用家庭锻炼干预的框架是否可行 合作小组(合作社区肿瘤项目(CCOP))和SHOW 承诺在更大的群体环境中进行进一步测试，如癌症和 白血病B组(CALGB)。 我们根据最先进的健身方式调整了我们的计划 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)，以及电话咨询方案。 我们还获得了维克森林研究基地CCOP的支持 美国确定以家庭为基础的锻炼计划是否有希望 使用合作社的基础设施实施和测试可行 一群人。我们提出了一项研究，将衡量一项单独的锻炼或 运动加饮食干预预防体重增加和不良变化 在身体成分，减少抑郁，提高生活质量和 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 球蛋白和脂蛋白图谱)。我们建议进行一项试点研究，在那里 在90年中，将在基线和诊断后6个月评估终端 绝经前早期乳腺癌患者将接受辅助治疗 化疗和随机分组进入1/3的研究组(注意 控制、单独锻炼或锻炼加节食)。如果数据显示前景看好，则进一步 将继续进行更大规模的研究-研究将侧重于测试 最佳干预，并根据已知的效果大小供电。

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.