A randomized controlled trial to assess the efficacy and safety of RACOL for adverse events such as stomatitis and malnutrition during adjuvant chemotherapy of gastric cancer patients
Not Applicable
- Conditions
- Gastric cancer performed adjuvant chemotherapy
- Registration Number
- JPRN-UMIN000032442
- Lead Sponsor
- Gunma University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with drug allergy of omega-3 faty acid-containing enteral nutrition. 2) patients with severe complications (heart disease, pulumonary 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 patient who was considered ineligible by the investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of stomatitis and malnutrition
- Secondary Outcome Measures
Name Time Method 1) The incidence of non-hematotoxicity (anorexia, diarrhea, vomiting) 2) The incidence of hematotoxicity 3) Completion rate of chemotherapy