Evaluating the Effects of Dietary Supplementation With Remune on Cancer Associated Weight and Muscle Loss With and Without Exercise: A Randomized Pilot Feasibility Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Adherance
研究概览
简要总结
The main purpose of this research study is to determine if the use of a nutritional supplement and 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 and nutritional supplements may impact this process. The investigator would like to see whether a nutritional supplement (Remune) with or without a walking and progressive resistance exercise program (EXCAP©®, Exercise for Cancer Patients) can improve symptoms in patients with lung or gastrointestinal cancers with weight loss and cachexia. The investigator would also like to find out if this nutritional supplement and exercise intervention improves physical performance, day-to-day function, quality of life, and how the supplement and/or 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
- •Be over the age of 18 years and have a primary diagnosis of colorectal, esophageal, gastric, pancreatic, biliary tract cancer (includes cholangiocarcinoma, gallbladder cancer, and ampullary cancer), or Non-small cell lung cancer (NSCLC) with plans to initiate systemic chemotherapy, targeted therapy or immunotherapy within the next 4 weeks after enrollment.
- •Have been diagnosed as having an 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.
- •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 perform low-to-moderate intensity exercise regimen.
- •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 (67).
- •Use of nutritional supplements containing EPA/DHA within 2 weeks prior to screening
- •Current Use of Vitamin D supplementation or St. John's wort that can influence efficacy and safety parameters. Chronic treatment (>12 weeks prior to screening) with multivitamin tablets is allowed (vitamin tablets must not contain more vitamin D than 150% of the recommended dietary allowance [RDA]).
- •Known hypersensitivity or allergy to any of the study products. Specifically, patients allergic to milk, fish or shellfish will be excluded.
- •Have AST/ALT >3x upper limit of normal (ULN) or >5xULN in those with liver metastases, Serum creatinine >2x ULN, Absolute Neutrophil Count <1,500/uL, Hemoglobin <9, Platelet count <75,000/uL at the time of baseline blood draw or any other Blood chemistry or hematology lab abnormalities that would exclude them from being able to receive standard chemotherapy or interventional clinical trial.
- •Have uncontrolled Diabetes Mellitus as determined by primary oncologist or PI.
研究组 & 干预措施
Remune dosed twice daily
A nutritional supplement taken twice per day each day and standard care for your cancer as prescribed by your oncologist
干预措施: Remune (Drug)
Remune dosed twice daily and daily exercise with EXCAP
A nutritional supplement taken twice by day each day and a home-based exercise intervention as well as standard care for your cancer as prescribed by your oncologist
干预措施: Remune (Drug)
Remune dosed twice daily and daily exercise with EXCAP
A nutritional supplement taken twice by day each day and a home-based exercise intervention as well as standard care for your cancer as prescribed by your oncologist
干预措施: EXCAP©® (Other)
结局指标
主要结局
Adherance
时间窗: 3 months
Did 70% of subjects in the supplement arm consume 60% of supplement evening. Patients are asked to report the number of cartons of Remune consumed each day and how much they consumed
Recruitment and Retention
时间窗: 3 months
Recruitment of 45 patients (15 per arm) and at least 10 evaluable patients in each arm for retention rate of 66%
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 3 months
measured by adverse event severity and quantity
次要结局
- Proportion of subjects that improve physical function- Power(3 months)
- Porportion of subjects with improved cachexia-related symptoms 3 months(3 months)
- Proportion of subjects that improve physical function- Muscle Strength(3 months)
- Proportion of subjects that improve physical function- Walking(3 months)
研究者
Richard Dunne
Assistant Professor - Department of Medicine , Hematology/Oncology
University of Rochester