Use of a Soy-Based Meal Replacement Weight Loss Intervention for Survivors of ER/PR Negative Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
研究概览
简要总结
RATIONALE: A diet using a soy-based meal replacement may help survivors of breast cancer lose weight and improve their quality of life.
PURPOSE: This clinical trial is studying how well a soy-based meal replacement works in helping women with stage I, stage II, or stage III breast cancer in complete remission lose weight.
详细描述
OBJECTIVES:
- Determine the ability to recruit survivors of estrogen receptor/progesterone receptor (ER/PR)-negative stage I-III breast cancer to participate in a 3-month, soy-based, meal-replacement (Almased®) weight loss intervention.
- Assess the patient's ability to adhere to this intervention protocol.
- Measure changes in anthropometrics (body weight, bioelectrical impedance, waist circumference) and biomarkers (serum levels of glucose, insulin, highly specific C-reactive protein, insulin-like growth factor, insulin-like growth factor binding protein-3, lipids).
- Measure changes in health-related quality of life.
OUTLINE: This is a prospective, longitudinal, pilot study.
Patients undergo goal-oriented, cognitive-behavioral therapy comprising group counseling weekly for 3 weeks and individual counseling once a month. Weight loss interventions include behavioral techniques, dietary modification (using a portion-controlled diet and soy-based meal-replacement [Almased®] once or twice daily), physical activity (≥ 15 minutes per day, 6 days a week), and social support. Weight loss is monitored weekly and patients complete daily logs of dietary intake and physical activity. Therapy continues for 12 weeks.
Health-related quality of life is assessed at baseline and then weekly for 12 weeks.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 21 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Previously diagnosed stage I-III breast cancer currently in complete remission
- •Completed treatment for breast cancer ≥ 6 months ago
- •Free of disease at last clinic visit
- •Body mass index ≥ 27
- •Hormone receptor status
- •Estrogen receptor (ER)/progesterone receptor (PR) negative
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •No history of soy allergies
- •No uncontrolled blood pressure
- •No uncontrolled hyperthyroidism or hypothyroidism
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No diabetes mellitus (type 1 or 2)
- •No medical, psychiatric, or behavioral factors that would preclude study participation
- •No definite plans to move out of the area during the study period
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No concurrent medications for weight loss
- •No concurrent treatment for ER/PR-negative disease
排除标准
- 未提供