The Women In Steady Exercise Research (WISER) SurwVor Trial

女性稳定运动研究 (WISER) SurwVor 试验

• 批准号: 8072522
• 负责人: Kathryn H. Schmitz
• 金额: $ 57.57万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-06-24 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8072522
• 关键词: Adverse effects; Aerobic Exercise; Appearance; Biological Markers; Body Weight decreased; Breast Cancer Treatment; Caloric Restriction; Cancer Survivor; Caring; Chronic; Clinical; Control Groups; Event; Exercise; Face; Fright; Goals; Gonadal Steroid Hormones; Growth Factor; Human; Intervention; Intervention Trial; Life Style; Lymphedema; Medical; Mus; Obesity; Outcome; Oxidative Stress; Postmenopause; Quality of life; Randomized; Recurrence; Recurrent disease; Research; Risk; Sample Size; Survivors; Swelling; Symptoms; T-Cell Receptor-Rearrangement Excision DNA Circles; Testing; Weight Lifting; Woman; Work; adipokines; angiogenesis; arm; cancer recurrence; cancer therapy; cohort; energy balance; improved; inflammatory marker; innovation; intervention effect; malignant breast neoplasm; mouse model; novel; novel strategies; sedentary; treatment effect; weight loss intervention

Breast cancer survivors face dual challenges: 1) risk of recurrent disease and 2) dealing with the long term sequelae of their treatments. Facing these challenges can be burdensome, resulting in reduced quality of life. Obesity and sedentary lifestyle further complicate these issues. The goal ofthe WISER Survivor trial is to assess the effects of exercise and/or weight loss through caloric restriction on a common long term adverse effect of treatment (lymphedema), biomarkers for recurrence, and quality of life. Lymphedema is a chronic, progressive, incurable condition characterized by arm swelling and negative alterations in function and appearance, as well as bothersome symptoms. It is among the more common, expensive, and feared persistent adverse breast cancer treatment effects. In our completed work, twice weekly weight-lifting reduced by half the number of incident clinical lymphedema events requiring medical care. In the proposed WISER Survivor trial we seek to assess whether adding aerobic exercise or weight loss through caloric restriction to the weight-lifting intervention further improves lymphedema clinical outcomes. The WISER Survivor Trial will also test the effects ofthe exercise and weight loss interventions on the same recurrence biomarkers to be tested in the mouse model study (Project 1). The biomarkers include sex hormones, markers of inflammation, growth factors, adipokines, and oxidative stress. The innovation of these two paired projects include the novel approach of assessing effects of these interventions in the recurrence setting, as well as comparing effects on biomarkers in equivalent interventions in mice and humans. In addition, we assess effects of our energy balance interventions on a novel biomarker related to pathogenic angiogenesis. Another innovation includes a unique opportunity to assess whether changes in any of these biomarkers are correlated with clinical lymphedema outcomes. Finally, we seek to assess effects of our interventions on quality of life in breast cancer survivors with lymphedema. Therefore, we propose a one year randomized controlled weight loss and exercise intervention trial in a multi-ethnic cohort of oven/veight and obese post-menopausal breast cancer survivors with clinically confirmed lymphedema. There will be four groups in this trial: exercise only, weight loss only, exercise and weight-loss combined, and a control group, with a sample size of 125 per group (total N=500).

乳腺癌幸存者面临双重挑战：1）复发疾病的风险和2）处理其治疗的长期后遗症。面对这些挑战可能是沉重的负担，导致生活质量下降。肥胖和久坐不动的生活方式使这些问题进一步复杂化。WISER Survivor试验的目的是评估运动和/或通过热量限制减肥对治疗常见的长期不良反应（水肿）、复发生物标志物和生活质量的影响。 淋巴水肿是一种慢性、进行性、无法治愈的疾病，其特征是手臂肿胀、功能和外观的负面改变以及令人烦恼的症状。它是最常见的，昂贵的，令人担忧的持续不良乳腺癌治疗效果。在我们完成的工作中，每周两次举重使需要医疗护理的临床水肿事件减少了一半。在拟议的WISER Survivor试验中，我们试图评估在举重干预中增加有氧运动或通过热量限制减肥是否能进一步改善水肿的临床结局。 WISER幸存者试验还将测试运动和减肥干预对小鼠模型研究（项目1）中测试的相同复发生物标志物的影响。生物标志物包括性激素、炎症标志物、生长因子、脂肪因子和氧化应激。这两个配对项目的创新之处包括评估这些干预措施在复发环境中的效果的新方法，以及比较小鼠和人类等效干预措施对生物标志物的影响。此外，我们评估了我们的能量平衡干预措施对与致病性血管生成相关的新生物标志物的影响。另一项创新包括评估这些生物标志物中任何一种的变化是否与临床水肿结果相关的独特机会。最后，我们试图评估我们的干预措施对患有水肿的乳腺癌幸存者生活质量的影响。 因此，我们提出了一项为期一年的随机对照减肥和运动干预试验，在多种族队列的烤箱/veight和肥胖的绝经后乳腺癌幸存者与临床证实的水肿。本试验将分为四组：仅运动组、仅减肥组、运动和减肥联合组以及对照组，每组样本量为125例（总N=500）。