The Effect of Nutrition for the Colorectal Cancer Patients Receiving Chemotherapy-randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Assessment of adverse event
研究概览
简要总结
We use clinical trial to explore the effect of nutrition support in colorectal cancer patients receiving postoperative adjuvant chemotherapy.
详细描述
Colorectal cancer is the most common cancer in Taiwan. Side effects induced by postoperative adjuvant chemotherapy will affect nutrition status and may delay treatment and affect prognosis. Sarcopenia may be noted in some patients and increase the toxicities of chemotherapy. The studies of intervention include nutrition consultant and treatment like protein, fish oil or Vitamin D supplement. Premium amino acids include multiple amino acids and organic Selenium and have effect in inhibition of tumor proliferation according to colorectal cancer cell and animal experiments.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 20
- •Radical operation for stage III and stage II with high risk colorectal cancer
- •Agree to join the trial and sign the informed consent form
排除标准
- •Unable to receive chemotherapy
- •Unstable vital sign
- •Not suitable after evaluation by Principal Investigator
结局指标
主要结局
Assessment of adverse event
时间窗: 2 weeks after chemotherapy
Evaluation of adverse event(Grade 1-4) between control group and experimental group before every chemotherapy(total 12 times)
2)Nutrition assessment
时间窗: 2 weeks after chemotherapy
pre-albumin level between two group before every chemotherapy(total 12 times)
1)Sarcopenia assessment muscle power
时间窗: At 12th cycle of chemotherapy (each cycle is 2 weeks).
1-2)Assessment with Grip strength(Kg)
3)Sarcopenia assessment
时间窗: At 12th cycle of chemotherapy (each cycle is 2 weeks).
3-2)Assessment with speed(m/s)
1)Nutrition assessment
时间窗: 2 weeks after chemotherapy
albumin level between two group before every chemotherapy(total 12 times)
2)Sarcopenia assessment muscle power
时间窗: At 12st cycle of chemotherapy (each cycle is 2 weeks).
2-2)Assessment with ASM/heigh2(Kg/m2)
5)Sarcopenia assessment
时间窗: At 12th cycle of chemotherapy (each cycle is 2 weeks).
5-2)Assessment with abdominal CT
4)Sarcopenia assessment
时间窗: At 12th cycle of chemotherapy (each cycle is 2 weeks).
4-2)Assessment with DXA(g/cm2)
次要结局
未报告次要终点
研究者
Wan-Hsiang Hu
Attending physician
Chang Gung Memorial Hospital