Oral Nutritional Supplements Compared With Standard Diet in Postoperative Gastric Cancer Patients With Adjuvant Chemotherapy: a Multicenter, Open-label, Phase 3 Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 374
- 试验地点
- 1
- 主要终点
- postoperative malnutrition
研究概览
简要总结
Background: It is known that postoperative malnutrition remains inevitable for gastric cancer patients with adjuvant chemotherapy, which could have prejudicial influence on the compliance of subsequent adjuvant chemotherapy and survival of the patients. A multi-institutional prospective phase 2 study had demonstrated the efficacy of oral nutritional supplements (ONS) for gastric cancer patients undergoing gastrectomy. However, previous studies did not focus the gastric cancer patients with adjuvant chemotherapy. Thus, it is unknown whether the ONS could benefit the gastric cancer patients with adjuvant chemotherapy. A multicenter, phase 3 randomised controlled trial was conducted to compare the ONS with standard diet for postoperative gastric cancer patients with adjuvant chemotherapy. Patients and method: In this study, pathological confirmed stage II-III or T1N1M0 gastric cancer patients who are supposed to receive adjuvant chemotherapy, aged from 18 to 75 years, with body mass index (BMI) from 18.5 to 28.0 kg/m2, and with Eastern Cooperative Oncology Group performance status ≤2, are randomized 1:1 to receive oral administration of NutrenOpimum (Nestle Suisse S.A.), a liquid enteral nutritional food for special medical purpose (FSMP), or standard diet. NutrenOpimum administration was recommended with a dosage of 400 kcal/400 ml per day within 7 days postoperatively and was continued for 3 months postoperatively. The primary end point was postoperative malnutrition, as defined as ratio of the weight loss at 3 months postoperatively to the days 7 postoperatively body weight (body weight loss ratio) higher than 10%; body weight loss ratio at 1, 3, 6 months. Secondary end points were chemotherapy withdrawal, time to adjuvant chemotherapy failure, period of adjuvant chemotherapy, quality of life, grade 3/4 neutropenia, thrombocytopenia, anemia, and severe side effects on digestive tract. Final study analysis will be conducted after the last patient's enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •be proven to be primary adenocarcinoma of gastric cancer and pathological confirmed stage II-III or T1N1M0
- •age: 18-75 years
- •Eastern Cooperative Oncology Group performance status: 0~2
- •body mass index: 18.5-28.0kg/m2
- •able to ingest semiliquid diet
- •without other malignancies with exception of the cured cervical carcinoma in situ and basal cell carcinoma
- •anticipated overall survival time ≥ 6 months
- •anticipated period of adjuvant chemotherapy ≥ 3
- •without severe mental disorder
- •without severe digestive disease
- •without Acquired Immune Deficiency Syndrome or diabetes mellitus
- •without communication barrier
- •informed consensus of patients
排除标准
- •with unstable hemodynamics
- •with severe nausea or vomit which cannot be controlled by drugs
- •allergic reaction to NutrenOpimum
- •dysfunction of other organs
- •with severe disease, such as infection, stroke, heart failure or stock
- •other situation to be judged not adaptive to the study by investigators
研究组 & 干预措施
oral nutritional supplements
NutrenOpimum administration was recommended with a dosage of 400 kcal/400 ml per day within 7 days postoperatively and was continued for 3 months postoperatively.
干预措施: NutrenOpimum (Dietary Supplement)
standard diet
The control group was given no additional postoperative nutritional supplementation (standard diet).
结局指标
主要结局
postoperative malnutrition
时间窗: 3 months postoperatively
the weight loss at 3 months postoperatively to the days 7 postoperatively body weight (body weight loss ratio) higher than 10%
body weight loss ratio at 1, 3, 6 months
时间窗: 1,3,6 months postoperatively
the ratio of the weight loss at 1,3,6 months postoperatively to the days 7 postoperatively body weight
次要结局
- chemotherapy withdrawal(6 months)
- time to adjuvant chemotherapy failure(6 months)
- period of adjuvant chemotherapy(6 months)
- quality of life(6 months)
- grade 3/4 neutropenia, thrombocytopenia, anemia(6 months)
- severe side effects on digestive tract(6 months)
研究者
Zhou Zhiwei
Professor
Sun Yat-sen University