The Impact of Sarcopenia and the Effect of Multimodal Rehabilitation on the Prognosis of Rectal Cancer Patients Receiving Concurrent Chemoradiotherapy- Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Sarcopenia assessment with muscle power
研究概览
简要总结
Investigators use clinical trial to explore the role of sarcopenia and multimodal rehabilitation in prognosis of rectal cancer patients receiving concurrent chemoradiotherapy.
详细描述
The impact of sarcopenia and the effect of multimodal rehabilitation will be evaluated in the rectal cancer patients receiving pre-operative concurrent chemoradiotherapy. This is a randomized trial.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •rectal cancer patients receiving concurrent chemoradiotherapy
- •agree to join the trial and sign the informed consent form
排除标准
- •unstable vital sign
- •unable to excise
- •not suitable after evaluation by Principal Investigator
结局指标
主要结局
Sarcopenia assessment with muscle power
时间窗: 3 months later
Assessment with Grip strength(Kg)
Sarcopenia assessment with speed
时间窗: 3 months later
Assessment with speed(m/s)
Sarcopenia assessment with DXA
时间窗: 3 months later
Assessment with DXA(g/cm2)
Sarcopenia assessment with abdominal CT
时间窗: 3 months later
Assessment with ASM/heigh2(Kg/m2) of L3 level
Nutrition assessment with albuminemia
时间窗: 3 months later
albumin level in serum
Nutrition assessment with pre-albuminemia
时间窗: 3 months later
pre-albumin level in serum
Nutrition assessment with PGSGA
时间窗: 3 months later
patient-generated subjective global assessment Scale (Total score 0\~9 ;score 1-3 Good nutritional intake. score 4-8 Moderate malnutrition. score \>9Severe malnutrition)
Psychological assessment
时间窗: 3 months later
Taiwanese Depression Questionnaire (TDQ)Total score 0-54; score \>8 emotionally stable ;Score 9 \~ 14 Pay attention to emotional changes Score 15 \~ 18 pressure load reaches the critical point; Score 19-28 It is recommended to find a professional institution or medical unit assistance ;Scores 29 or more must find professional medical units to get involved
Harris Benedict Equation
时间窗: 3 months later
Total Daily Energy Expenditure
次要结局
未报告次要终点
研究者
Wan-Hsiang Hu
Attending physician
Chang Gung Memorial Hospital