NCT00689975已完成不适用
The Effects of a Combined Diet and Exercise Intervention on Biomarkers Associated With Disease Recurrence After Breast Cancer Treatment: The Sheffield DEBRA Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
RATIONALE: Studying diet and exercise interventions in overweight and obese patients with breast cancer may help doctors learn more about how to help patients lose weight and change their body composition.
PURPOSE: This randomized clinical trial is studying diet and exercise to see how well it works compared with normal care in overweight or obese women who have undergone treatment for stage I, stage II, or stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- To examine the effects of a dietary and exercise intervention on body weight and body composition in overweight or obese women who have undergone breast cancer treatment.
- To examine the effects of a dietary and exercise intervention on indices of psychological health status and biomarkers associated with disease recurrence in overweight or obese women who have undergone breast cancer treatment.
Secondary
- To examine the relationship between change in body weight and biomarkers associated with disease recurrence and physiological health status, including circulating levels of estrogen, C-reactive protein, and interleukin-6.
- To examine the relationship between changes in psychological health status, circulating stress hormones, and indices of immune function.
- To examine the effects of the dietary and exercise intervention on broader quality-of-life dimensions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of stage I, II, or III breast cancer
- •No metastatic breast cancer
- •No inoperable or active loco-regional disease
- •Body mass index (BMI) > 25
- •Patients must have completed treatment for breast cancer within the past 3-18 months
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •Willing and able to attend supervised exercise sessions at least 3 times per week for a period of 24 weeks
- •Patients must be an exercise pre-contemplator, contemplator, or preparer as defined by the transtheoretical model
- •No physical/psychiatric impairment that would seriously impair physical mobility
- •No severe nausea, anorexia, or other diseases affecting health (e.g., arthritis and multiple sclerosis)
- •More than 3 months since prior exercise and not currently engaged in exercise (two or more times per week for at least 30 minutes per session)
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Concurrent tamoxifen, other endocrine treatments, and trastuzumab (Herceptin®) allowed
- •No concurrent alternative/complementary diets
- •No concurrent high-dose antioxidant supplement therapy
- •More than 4 months since prior and no concurrent hormone-replacement therapy or oral contraceptives
排除标准
- 未提供
结局指标
主要结局
Body weight
Body composition
次要结局
- Pychological stress via the Perceived Stress Scale
- Depression via the Beck Depression Inventory II
- Cardiorespiratory fitness
- Quality of life via the FACT-G and FACT-B
研究者
研究点 (1)
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