Evaluating the Effects of a 12 Week Home-based Exercise Intervention on Physical Performance in Patients With Cancers of the Gastrointestinal Tract With Pre- Cachexia or Cachexia: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Number of patients that adhered to the exercise conditions of the study
研究概览
简要总结
The main purpose of this research study is to determine if exercise improve or worsen cachexia.
详细描述
In this study the investigator would like to better understand how cachexia may improve or worsen, and how exercise may impact this process. The investigator would like to see whether a progressive resistance exercise program (EXCAP©®, Exercise for Cancer Patients) can improve symptoms in patients with gastrointestinal cancers with weight loss and cachexia. The investigator would also like to find out if this exercise intervention improves physical performance, day-to-day function, quality of life, and how exercise may affect different markers in the blood over time.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Have a primary diagnosis of colorectal, esophageal, gastric, pancreatic or biliary tract cancer and plans to initiate systemic chemotherapy within the next 4 weeks after enrollment.
- •Have been diagnosed as having an advanced unresectable cancer with no plans for surgical intervention during the active study period (12 weeks).
- •Have an ECOG performance score of 0 or
- •Have a life expectancy of >3 months as determined by their primary oncologist.
- •Have experienced at least 2% weight loss of the patient's reported previous body weight over the 6 months prior to enrollment. Patients who have 2 - 4.9% weight loss should also have one of the following metabolic changes: a hemoglobin level <13, an albumin level <3.5, and/or impaired glucose tolerance within the past year such as a new diagnosis of diabetes, an A1C level >5.7, a random glucose level >200 or a fasting glucose level >
- •Have permission from primary oncologist to engage in low to moderate intensity exercise regimen.
- •Be able to read English (since the assessment materials are in printed format).
- •Be able to give written informed consent.
排除标准
- •Have any of the following limitations: unable to walk the 4 meters of the SPPB test, wheel-chair bound, unable to perform low-to-moderate intensity exercise regimen (patients unable to perform 6 minute walk or stair climb test will be allowed to participate, but will be held out of these measurements).
- •Have had major surgery (excluding diagnostic procedures like laparoscopy, EGD/EUS, esophageal stent placement) in the past 4 weeks.
- •Be experiencing dysphagia that requires enteral or parenteral feeding for nutrition.
- •Be enrolled on hospice at time of consent.
- •Be engaged in an active exercise routine by being identified as in the Active or Maintenance Stage of exercise behavior as assessed by the 1-item Exercise Stages of Change Short Form (40).
结局指标
主要结局
Number of patients that adhered to the exercise conditions of the study
时间窗: 3 Months
Measured by the Short Physical Performance Battery (SPPB) in patients with advanced GI malignancies
次要结局
- Porportion of subjects with improved cachexia-related symptoms 3 months(3 Months)
研究者
Richard Dunne
Assistant Professor - Department of Medicine , Hematology/Oncology
University of Rochester