A Multicenter, Open-label, Parallel Controlled, Prospective Cohort Study Evaluating Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- the incidence of chemotherapy related adverse reactions
研究概览
简要总结
Evaluate the effects of Suyusu (immunonutrition) in postoperative adjuvant chemotherapy for gastrointestinal cancer patients. The main endpoint of the study was the incidence of chemotherapy related adverse reactions (including bone marrow suppression, nausea and vomiting, diarrhea, and mucositis) in patients after two cycles of chemotherapy. The secondary endpoint indicators were: quality of life score (EORTC-QLQ-C30), nutritional risk score (PG-SGA, NRS2002), nutritional assessment indicators, changes in immune microenvironment, analysis of psychological status, survival time (1-year progression free survival rate), treatment tolerance (dose intensity, rate of treatment interruption, delay), etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily and sign an informed consent form;
- •Age ≥ 18 years old and ≤ 75 years old;
- •Patients with stage II-III gastrointestinal malignancies with clear pathological diagnosis and undergoing radical surgery
- •No adjuvant chemotherapy received after surgery
- •The Eastern Cancer Collaborative Group's Physical State Score (ECOG) is 0-2 points;
- •No contraindications to chemotherapy and the use of fluorouracil based chemotherapy regimens;
排除标准
- •Allergy to the components of immune nutrients, allergic constitution, or other inability to eat;
- •Participated in other drug or food clinical trials within 2 months prior to enrollment;
- •Having a history of immune deficiency, including HIV testing positive, or having other acquired or congenital immune deficiency diseases, or having a history of organ transplantation, or active infections that are not suitable for chemotherapy (as determined by the researcher);
- •Subjects cannot guarantee compliance after participating in the study;
- •Other researchers believe that it is not suitable for enrollment.
研究组 & 干预措施
Placebo Group
normal diet group
干预措施: fluorouracil based chemotherapy regimens (Drug)
Immunonutrition Group
Immunonutrition (Suyusu) 250ml oral twice one day d1-d21 for two cycles
干预措施: Immunonutrition （Su yusu) (Drug)
Immunonutrition Group
Immunonutrition (Suyusu) 250ml oral twice one day d1-d21 for two cycles
干预措施: fluorouracil based chemotherapy regimens (Drug)
结局指标
主要结局
the incidence of chemotherapy related adverse reactions
时间窗: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
including bone marrow suppression, nausea and vomiting, diarrhea, and mucositis and so on.
次要结局
- nutritional risk score(the first two cycles of chemotherapy. (each cycle is 21 days))
- quality of life score(the first two cycles of chemotherapy. (each cycle is 21 ± 3 days))
- survival time(1-year)
- changes in immune microenvironment(the first two cycles of chemotherapy. (each cycle is 21 ± 3 days))
- treatment tolerance(the first two cycles of chemotherapy. (each cycle is 21 ± 3 days))
研究者
Yunpeng Liu
Clinical Professor
China Medical University, China