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）疾病复发的风险，2）应对治疗的长期后遗症。面对这些挑战可能会造成负担，导致生活质量下降。肥胖和久坐的生活方式使这些问题进一步复杂化。 WISER Survivor 试验的目标是评估通过热量限制进行运动和/或减肥对常见的长期治疗不良反应（淋巴水肿）、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。它是乳腺癌治疗中最常见、最昂贵且令人担忧的持续不良反应之一。在我们完成的工作中，每周两次举重将需要医疗护理的临床淋巴水肿事件数量减少了一半。在拟议的 WISER Survivor 试验中，我们试图评估在举重干预中添加有氧运动或通过热量限制来减轻体重是否会进一步改善淋巴水肿的临床结果。 WISER 幸存者试验还将测试运动和减肥干预措施对小鼠模型研究（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，以及比较对小鼠和人类的同等干预措施对生物标志物的影响。此外，我们还评估了能量平衡干预措施对与致病性血管生成相关的新型生物标志物的影响。另一项创新包括一个独特的机会来评估这些生物标志物的变化是否与临床淋巴水肿结果相关。最后，我们试图评估我们的干预措施对患有淋巴水肿的乳腺癌幸存者生活质量的影响。 因此，我们建议在多种族队列中进行为期一年的随机对照减肥和运动干预试验，其中包括经临床证实患有淋巴水肿的肥胖绝经后乳腺癌幸存者。本试验将分为四组：仅运动组、仅减肥组、运动加减肥组、对照组，每组样本量为 125 人（总共 N=500）。