Comparison of Weight Loss Among Early Stage Breast Cancer Patients Post Chemotherapy: Nutrition Education in Combination With Weight Loss Acupuncture Vs. Nutrition Education Alone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Weight Loss
研究概览
简要总结
This study looks at the benefit of adding acupuncture to nutrition education for weight loss in women with early stage breast cancer post-chemotherapy.
详细描述
Obesity and weight gain are significant concerns for breast cancer survivors. Given the adverse consequences of weight gain after diagnosis, continued efforts to identify appropriate weight management interventions aimed at promoting overall health and long term survivorship are needed. In this study, the investigators will examine whether adding acupuncture to a nutrition education program for weight loss could improve short and long term weight loss among breast cancer survivors post treatment with chemotherapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman with a diagnosis of breast cancer, stage I, II, or III
- •ECOG performance status ≤ 1
- •Received treatment for breast cancer, and treatment must have been completed at least 2 weeks prior to enrollment in trial, but no longer than 1 year post-treatment.
- •Adequate bone marrow and organ function as determined by the consenting/enrolling investigator
- •Signed informed consent
- •Any receptor status
- •Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits, and examinations
排除标准
- •Current chemotherapy or radiation therapy. Participants in study may still be receiving hormone or Herceptin treatment.
- •Diagnosis of metastatic breast cancer
- •Participation in other diet-based weight loss programs (ie. Patient should not be currently enrolled in Weight Watchers, Jenny Craig, Nutrisystem, etc.)
- •Current use of commercial or natural/herbal weight loss supplements
- •Major surgery within 1 month of starting study program and patients must have recovered from any effects of major surgery
- •Other malignancies within the past three years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
- •Personal history of an eating disorder
- •Other serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection (including uncontrolled HIV, Hepatitis B or C), or any psychiatric disorder that prohibits obtaining informed consent
研究组 & 干预措施
Nutrition Education
Educational weight management group sessions alone
干预措施: Nutrition Education (Behavioral)
Nutrition Education Plus Acupuncture
Educational weight management group sessions in addition to weight loss acupuncture
干预措施: Nutrition Education (Behavioral)
Nutrition Education Plus Acupuncture
Educational weight management group sessions in addition to weight loss acupuncture
干预措施: Acupuncture (Procedure)
结局指标
主要结局
Weight Loss
时间窗: 24 weeks
次要结局
- Maintenance of weight loss(24 months)
- Recurrence of breast cancer(5 years)
研究者
Amy Tiersten
Associate Professor
Icahn School of Medicine at Mount Sinai