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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032442

Enrollment

Registered

2018-06-01

Start date

2018-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer performed adjuvant chemotherapy

Interventions

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. No medication

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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 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 over 4,000/mm3, under 12,000/mm3. Neutrophils over 2,000/mm3. Blood platelet count over 100,000/mm3. Hemoglobin over 9.5 g/dl. ALT,AST under 1.5 times the upper limit of normal. Total bilirubin under 1.2 mg/dl. ALP under 2.5 times the upper limit of normal. Creatinine under 1.2 mg/dl. BUN under 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) Siged, written informed concent is obtained.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The incidence of stomatitis and malnutrition	—

Secondary

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

Countries

Japan

Contacts

Public ContactAkiharu Kimura

Gunma University Hospital Gastroenterological Surgery

akimura@gunma-u.ac.jp027-220-8224

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026