Phase 3 Study of Enteral Nutrition Rich in Eicosapentaenoic Acid in Patients Receiving Chemotherapy for Gastric Cancer or Colorectal Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Serum level of proalbumin
研究概览
简要总结
Malnutrition is frequently seen in patients on chemotherapy suffering from gastric/colorectal cancer and may worsen the outcome. EPA, a sort of ω-3 PUFA, can modulate immune system. EPA also antagonizes metabolic and inflammatory changes induced by the tumor. This study is to test whether EPA, in combination with enteral nutrition, can improve nutritional/immunologic status, quality of life, and reduce chemotherapy related side effects of these patients.
详细描述
Chemotherapy is indispensible for patients suffering from advanced gastric or colorectal cancer, and also the main therapy for those with end-stage tumor. However, incidence of malnutrition during chemotherapy was reported as high as 60%. The mechanisms include anatomy modification of digestive tract, side effects of chemotherapy such as anorexia, nausea, vomiting, and inflammatory factors generated or induced by the tumor. Malnutrition may lead to discontinuation of the therapy, compromise of the anti-cancer effect, increase of toxicity and mortality. 20%-40% of patients with end-stage tumor ultimately died from malnutrition.
EPA (Eicosapentaenoic acid, molecular formula C20H30O2) belongs to ω-3 polyunsaturated fatty acid (ω-3 PUFA). EPA is one of the main constituent of fish oil. EPA decreases LPS-stimulated macrophage production of TNF-α, IL-1β, IL-6, and human B lymphocytes production of IL-10, TNF-α, IFN-γ. EPA can suppress cancer induced lipolysis, and enhanced the inhibitory effect of 5-Fu over cancer cell proliferation. However, cancer patients are always lack of EPA.
Nutriall is a sort of non-elemental diet. The kind of powder is produced by Guangdong Academy of Agriculture Science. Every 50 grams of nutriall contains 9.3mg of VitC and 0.8mg of VitE. For this enteral nutrition preparation, there have been evidences of protective effects on nutritional status during chemotherapy on lung cancer. However, this kind of preparation does not contain EPA.
Up to date, there has been no RCT which testified whether therapeutic dosage of EPA plus enteral nutrition has combined effects on patients receiving chemotherapy. The investigators choose nutriall as basic nutritional support agent during chemotherapy, and give patients different dosage of EPA. Nutritional and immunologic status, quality of life and side effects of chemotherapy are recorded to evaluate whether EPA can improve outcome of these patients. Through this study the investigators may also optimize the dose of EPA for patients receiving chemotherapy on gastric/colorectal cancer.
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
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The cases have undergone radical excision on gastric cancer or colorectal cancer.
- •Without contraindication for chemotherapy.
- •Eligible for postoperative adjuvant XELOX chemotherapy.
- •Capable of taking in food or drug orally.
- •Without severe absorption dysfunction
- •Able and willing to give written, informed consent
排除标准
- •Comorbidities: diseases of hematology or immunology system; hepatic or renal dysfunction; metabolic diseases.
- •BMI>35kg/m2
- •Life expectancy≤3mo
- •The chemotherapy treatment is palliative.
- •The patient has received radiotherapy or neoadjuvant chemotherapy prior to the operation.
研究组 & 干预措施
EN
The subjects take in 150g of Nutriall per day. Oral administration of the liquid is divided into 3 times per day. The treatment lasts for 21d. During the test period patients are treated with the first course of XELOX.
干预措施: Nutriall (Drug)
EN
The subjects take in 150g of Nutriall per day. Oral administration of the liquid is divided into 3 times per day. The treatment lasts for 21d. During the test period patients are treated with the first course of XELOX.
干预措施: Placebo (Drug)
EN
The subjects take in 150g of Nutriall per day. Oral administration of the liquid is divided into 3 times per day. The treatment lasts for 21d. During the test period patients are treated with the first course of XELOX.
干预措施: Chemotherapy (Drug)
ENLDEPA
The subjects take in the same dose of Nutriall for the same duration as those in EN group. In addition, they take in 3 grams of EPA per day during the 21 days of treatment. The patients are treated with the first course of XELOX.
干预措施: Nutriall (Drug)
ENLDEPA
The subjects take in the same dose of Nutriall for the same duration as those in EN group. In addition, they take in 3 grams of EPA per day during the 21 days of treatment. The patients are treated with the first course of XELOX.
干预措施: LDEPA (Drug)
ENLDEPA
The subjects take in the same dose of Nutriall for the same duration as those in EN group. In addition, they take in 3 grams of EPA per day during the 21 days of treatment. The patients are treated with the first course of XELOX.
干预措施: Chemotherapy (Drug)
ENHDPEA
The subjects take in the same dose of supportan for the same duration as those in EN group. In addition, they take in 6 grams of EPA per day during the 21 days of treatment. The patients are treated with the first course of XELOX.
干预措施: Nutriall (Drug)
ENHDPEA
The subjects take in the same dose of supportan for the same duration as those in EN group. In addition, they take in 6 grams of EPA per day during the 21 days of treatment. The patients are treated with the first course of XELOX.
干预措施: HDEPA (Drug)
ENHDPEA
The subjects take in the same dose of supportan for the same duration as those in EN group. In addition, they take in 6 grams of EPA per day during the 21 days of treatment. The patients are treated with the first course of XELOX.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Serum level of proalbumin
时间窗: The starting and ending day of the experiment for a certain subject (day1 and day21)
次要结局
- Serum level of Cortisol(The starting and ending day of the experiment for a certain subject (day1 and day21))
- Weight in light clothing(The starting and ending day of the experiment for a certain subject (day1 and day21))
- Height and BMI(The starting and ending day of the experiment for a certain subject (day1 and day21))
- mid upper arm circumference and triceps skinfold thickness(The starting and ending day of the experiment for a certain subject (day1 and day21))
- Fat ratio and fat mass(The starting and ending day of the experiment for a certain subject (day1 and day21))
- Fat-free mass, muscle mass and muscle function(The starting and ending day of the experiment for a certain subject (day1 and day21))
- CD distribution of T cells(The starting and ending day of the experiment for a certain subject (day1 and day21))
- Serum level of different types of immunoglobulin(The starting and ending day of the experiment for a certain subject (day1 and day21))
- Serum level of different types of cytokines(The starting and ending day of the experiment for a certain subject (day1 and day21))
- Serum level of transferrin(The starting and ending day of the experiment for a certain subject (day1 and day21))
- Serum level of ALT and AST(The starting and ending day of the experiment for a certain subject (day1 and day21))
- Serum level of creatine and BUN(The starting and ending day of the experiment for a certain subject (day1 and day21))
- Serum level of total triglyceride, total cholesterol, LDL, HDL(The starting and ending day of the experiment for a certain subject (day1 and day21))
- Records of EPA intake(The whole experiment period)
- Records of chemotherapy-associated side effects(The whole experiment period)
- Serum level of albumin(The starting and ending day of the experiment for a certain subject (day1 and day21))
- Serum level of CEA, CA125, CA199(The starting and ending day of the experiment for a certain subject (day1 and day21))
- Records of Nutriall intake(The whole experiment period)
- Records of food intake(The middle 3 days of the whole experiment period (day10, day11, day12))
研究者
Guanqing Sun
Dr.
Sun Yat-sen University