The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Percent interlimb difference, change over 12 months.
研究概览
简要总结
WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer survivors who are overweight or obese with breast cancer related lymphedema. There will be four groups in this trial: exercise only, weight loss only, exercise and weight-loss combined, and a control group. The primary purpose of this study is to test the effects of these interventions on clinical lymphedema outcomes. Secondary outcomes include weight loss, breast cancer related biomarkers, and quality of life. To the extent that funding will be available, participants will be followed long term to examine effects on recurrence and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
All participants asked at the start of each measurement encounter not to inform measurement staff of their randomization group status. All measurement staff asked to guess group status at end of each measurement encounter. Patterns of responses beyond chance result in corrective action to improve masking (e.g.; requests from PI for participants to mask group status)
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •breast cancer survivor
- •overweight or obese (BMI of 25 or greater)
- •must have breast cancer related lymphedema
- •at least 6 months post-treatment (e.g. surgery, chemotherapy, or radiotherapy) but there will be no upper limit on time elapsed from diagnosis
- •the eligible age range will have no lower limit.
- •currently free of cancer
排除标准
- •medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims
- •inability to walk for 6 minutes unaided
- •extremely obese (body mass index greater or equal to 50 kg/m2)
- •plans for additional (e.g. curative or reconstructive) surgery during the study period
- •self-report of weight-lifting within the past year
- •already engaging in 3 or more times weekly aerobic activity of moderate intensity
- •planning to move away from the area over the next year
- •current use of weight loss medication (OTC or prescription)
- •self-report of alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of more than 14 alcoholic drinks per week)
- •weight loss of greater than 10 % in the past 3 months
- •history of bariatric surgery
- •women who are pregnant
结局指标
主要结局
Percent interlimb difference, change over 12 months.
时间窗: Baseline and 12 months
Arm volumes for affected and unaffected limbs will be measured by perometry and the % difference will be determined at baseline and 12 months. the absolute percentage point difference of differences (% interlimb difference at 12 months minus % interlimb difference at baseline) will be the primary outcome
次要结局
- Clinical Lymphedema Events(Data collected over the 12 month follow-up, with events collected as reported)
- Weight loss(Baseline and 12 months)
- Biomarkers - Sex Hormone Binding Globulin(baseline and 12 months)
- F2-isoprostanes(baseline and 12 months)
- insulin like growth factor one(baseline and 12 months)
- Clinical Evaluation Score for Lymphedema(Baseline and 12 months)
- Leptin(baseline and 12 months)
- Biomarkers: Testosterone(baseline and 12 months)
- Insulin(baseline and 12 months)
- body image and relationship survey(baseline and 12 months)
- insulin like growth factor binding protein three(baseline and 12 months)
- Norman Lymphedema Survey(Baseline and 12 months)
- Biomarkers: Estradiol(baseline and 12 months)
- Adiponectin(baseline and 12 months)
- Glucose(baseline and 12 months)
- Upper limb lymphedema twenty seven(baseline and 12 months)
- Inflammation: Interleukin six(baseline and 12 months)
- Inflammation: C reactive protein(baseline and 12 months)