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

JRCT ID: jRCTs031180294

Registered date:15/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 01/10/2017
• Target sample size: 60
• Study type: Interventional

Intervention(s)

RACOL group: Administration of Racol(omega-3 fatty acid-containing enteral nutrition) once a day for 28days during 1 and 2 course of S-1 adjuvant therapy.
Control group: No medication except for S-1.

Outcome(s)

• Primary Outcome: The incidence of stomatitis and malnutrition

Secondary Outcome

1) The incidence of non-hematotoxicity (anorexia, diarrhea, vomiting)
2) The incidence of hematotoxicity
3) Completion rate of chemotherapy

Key inclusion & exclusion criteria

• Age minimum: 20age
• Age maximum: 75age
• Gender: Both

Include criteria

1) Patients who diagnosed as gastric cancer by cytology or histology.
2) Patients who will receive S-1 adjuvant chemotherapy.
3) Patients who diagnosed as Stage II-III gastric cancer.
4) Performance status (PS) 0 - 2.
5) Patients who don't receive chemotherapy or radiation.
6) Patients who can administer omega-3 fatty acid-containing enteral nutrition.
7) 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.
8) Patients with at least 3 months of life-expectancy.
9) Gender: unmentioned.
10) Inpatient admission or outpatient: unmentioned.
11) Signed, written informed concent is obtained.

Exclude criteria

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

Related Information

• Primary Sponsor: Ogata Kyoichi
• Source(s) of Monetary Support: Covidien Japan, Inc.,Shionogi &amp; Co., Ltd.
• Secondary ID(s): UMIN000032442