Feasibility Study of the PROTECT-trial (The Potential and Role Of Tertiary Prevention by Exercise in Colorectal Cancer Therapy)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Target sample size
研究概览
简要总结
The purpose of this study is to determine the feasibility of a one year exercise training program in post-surgical patients with colorectal cancer.
详细描述
Apart from a genetic predisposition lifestyle factors (low physical activity, nutrition, and obesity) increase the risk of colorectal cancer. Furthermore, in observational studies increased physical activity has shown to improve the prognosis in patients after the diagnosis of colorectal cancer. However, there are currently no prospective randomized controlled trials which prove the causal relationship between exercise and prognosis in colorectal cancer patients. The long-term aim of this study is to evaluate whether physical activity of ≥ 18 MET-h (Metabolic equivalent task-hours) per week significantly improves disease free survival in colorectal cancer survivors (stage UICC II/III). In the first instance, structure-, process- as well as outcome-characteristics need to be investigated within a feasibility study (F-PROTECT). Essential aims are to establish collaborations with clinics and training centres, to achieve the required recruitment numbers, and to conduct the training intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed nonhereditary primary Stage II or III colon cancer diagnosis or rectal cancer
- •written informed consent in German
- •histopathologically confirmed R0-resection
- •start of guideline conformed adjuvant chemotherapy within 12 weeks after R0-resection in Stage III colon cancer diagnosis (if necessary in Stage III colon cancer diagnosis)
排除标准
- •hereditary colon cancer diagnosis
- •R1 and R2 resection
- •clinically relevant complications during recovery
- •secondary neoplasm
- •non-continuance of guideline conformed therapy
- •uncontrolled infection
- •manifest cardiac disease (e.g. unstable CAD, heart failure (NYHA IV), malignant hypertension)
- •clinical relevant respiratory disease (GOLD IV)
- •musculoskeletal disorders severely restricting the patients mobility (e.g. gonarthrosis, coxarthrosis)
- •cirrhosis of the liver (Child B and C)
- •Karnofsky performance status scale ≤ 60%
- •maximal exercise capacity ≤ 50 watt
- •clinically relevant lab factors (leukocyte count ≤ 3000/μl, thrombocyte count ≤ 20.000/μl, hemoglobin < 8 g/dl)
- •physical activity level ≥ 18 MET-h/ week at screening
结局指标
主要结局
Target sample size
时间窗: one year
The primary outcome measure is to successfully recruit 50 colorectal cancer patients, and to achieve 70% compliance to regular exercise over one year.
次要结局
- Cancer related fatigue(at screening and 6 and 12 month after baseline)
- Adverse and serious adverse events(one year)
- Physical activity(at screening and 3, 6, 9, and 12 month after baseline)
- Peak oxygen consumption(at baseline and 12 month after baseline)
- Patient satisfaction(at 3, 6, 9, and 12 month after baseline)
- Anxiety and depression(at screening and 6 and 12 month after baseline)
- Cancer related quality of life(at screening and 6 and 12 month after baseline)
- Quality of life in colorectal cancer(at screening and 6 and 12 month after baseline)