Impact of Mechanism Based Acupuncture Intervention to Improve Weight Loss in GI Cancer Patients With Cachexia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Percentage weight change over 8 weeks between two arms
研究概览
简要总结
Patients with cancer often experience appetite loss and weight loss unintentionally. Rapid weight loss negatively impact on physical functioning, quality of life, and overall survival. Patients will be randomly assigned into two groups. An intervention with acupuncture may slow down or stop the progression of cancer-related anorexia and weight loss.
详细描述
The purpose of this research study is to investigate if acupuncture helps to improve appetite and slow down unintentional weight loss. The participants will be randomly divided into two groups and receive 8 sessions of acupuncture (two groups will receive different acupuncture points) for 8 weeks. During the study period, participants will be asked various questions about appetite, physical functioning, cancer-related symptoms and quality of life to understand changes related to body weight, as well as blood samples. The research team members will collect data regarding changes in appetite, body weight, body composition, and physical functioning.
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 (Participant)
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 year or older
- •medical diagnosis of gastrointestinal cancer (for example, gastric, biliary, or colorectal)
- •experienced weight loss of at least 5% over the last 6 months
- •ability to communicate in English
- •ability to follow the research protocol
排除标准
- •plan to have surgical procedures at the time of recruitment
- •receive radiation therapy alone or in addition to chemotherapy during the study period
- •undergo surgery during the study or in the months prior to the study
- •no plan to have chemotherapy after the surgery
- •any comorbidities that may affect the interpretation of study findings
- •open burn sites or infected wounds
- •esophageal cancer or pancreatic cancer
- •life expectancy of less than 6 months as assessed by attending physician
结局指标
主要结局
Percentage weight change over 8 weeks between two arms
时间窗: up to 8 weeks
Weight will be measured each visit (pounds).
次要结局
- Appetite change between two arms(up to 8 weeks)
- body composition(up to 8 weeks)
- physical functioning(up to 8 weeks)
