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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
The subjects take in 150g of Nutriall (Produced by Guangdong Academy of Agriculture Science. Every 50 grams of nutriall contains 9.3mg of VitC and 0.8mg of VitE) per day. Oral administration of the liquid is divided into 3 times per day. The treatment lasts for 21d.
The subjects take in 24 pils of EPA capsule per day. The medium is gelatine. Each capsule contains 0.125g of EPA and 0.125g of olive oil. The capsules are provided by nutritional department of our institute). The treatment lasts for 21d.
The subjects take in 24 pils of gelatin capsule (each contains 0.25g of olive oil, provided by nutritional department of our institute) per day. The treatment lasts for 21d.
The subjects take in 24 pils of EPA capsule per day. The medium is gelatine. Each capsule contains 0.25g of EPA. The capsules are provided by nutritional department of our institute). The treatment lasts for 21d.
Oxaliplatin 135mg/m2 d1,xeloda 1000mg/m2 d1-21. (XELOX)
First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGSerum level of proalbumin
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Weight in light clothing
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Height and BMI
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
mid upper arm circumference and triceps skinfold thickness
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Fat ratio and fat mass
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Fat-free mass, muscle mass and muscle function
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
CD distribution of T cells
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of different types of immunoglobulin
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of different types of cytokines
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of Cortisol
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of transferrin
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of ALT and AST
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of creatine and BUN
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of total triglyceride, total cholesterol, LDL, HDL
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Records of EPA intake
Time frame: The whole experiment period
Records of chemotherapy-associated side effects
Time frame: The whole experiment period
Serum level of albumin
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of CEA, CA125, CA199
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Records of Nutriall intake
Time frame: The whole experiment period
Records of food intake
Time frame: The middle 3 days of the whole experiment period (day10, day11, day12)
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