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

Not Applicable

• Conditions: Gastric cancer

• Registration Number: JPRN-jRCTs031180294
• Lead Sponsor: Ogata Kyoichi

Brief Summary

This study is a randomized controlled trial to assess the efficacy and safety of RACOL during adjuvant chemotherapy of gastric cancer patients. It was difficult to gather eligible patients. Finally, this study was finished without any registrant.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-15
• Study Completion: 2020-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

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 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.

Exclusion 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.

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) <br>2) The incidence of hematotoxicity <br>3) Completion rate of chemotherapy