A randomized controlled trial to assess the efficacy and safety of RACOL during adjuvant chemotherapy of gastric cancer patients

Completed

Recruitment & Eligibility

Inclusion Criteria

Patients who diagnosed as gastric cancer by cytology or histology.
Patients who will receive S-1 adjuvant chemotherapy.
Patients who diagnosed as Stage II-III gastric cancer.
Performance status (PS) 0 - 2.
Patients who don't receive chemotherapy or radiation.
Patients who can administer omega-3 fatty acid-containing enteral nutrition.
Patients whose function of main organ (bone marrow, heart, liver, kidney,lung, etc) are maintained and satisfy the following conditions. White blood cell count >= 4,000/mm3, <= 12,000/mm3. Neutrophils >= 2,000/mm3. Blood platelet count >= 100,000/mm3. Hemoglobin >= 9.5g/dl. ALT, AST <= 1.5 times the upper limit of normal. Total bilirubin <= 1.2mg/dl. ALP <= 2.5 times the upper limit of normal. Creatinine <= 1.2mg/dl. BUN <= the upper limit of normal.
Patients with at least 3 months of life-expectancy.
Gender: unmentioned.
Inpatient admission or outpatient: unmentioned.
Signed, written informed concent is obtained.

Exclusion Criteria

Patients with drug allergy of omega-3 fatty acid-containing enteral nutrition.
Patients with severe complications (heart disease, pulmonary fibrosis, interstitial pneumonia, bleeding tendency).
Patients with fever or severe infection.
Patients with active double cancer.
Patients with paralysis, peripheral neuropathy and edema.
Patients with active pleural or pericardial effusion.
Patients with severe drug allergy.
Patients who are pregnant, suspected to be pregnant or breastfeeding.
Patients with severe psychiatric disorder.
The patients with milk allergy.
The patients with ileus.
The patients without intestinal function.
The patients with severe liver or renal dysfunction.
The patients with severe diabetes mellitus.
The patients with congenital error of amino acid metabolism.
The patient who was considered ineligible by the investigators.

Primary Outcome Measures

Name	Time	Method
-		The incidence of stomatitis and malnutrition

Secondary Outcome Measures

Name	Time	Method
The incidence of non-hematotoxicity (anorexia, diarrhea, vomiting)		非血液毒性发生率（包括厌食、腹泻、呕吐）
The incidence of hematotoxicity		血液毒性发生率
Completion rate of chemotherapy		化疗完成率