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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

0

No person in the study

It was difficult to gather eligible patients. Finally, this study was finished without any registrant.

No person in the study

No person in the study

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.

June. 03, 2020

No

N/A

https://jrct.mhlw.go.jp/latest-detail/jRCTs031180294

Ogata Kyoichi

Gunma University Hospital

3-39-15, Showa-machi, Maebashi, Gunma, Japan

kogata@gunma-u.ac.jp

Kimura Akiharu

Gunma University Hospital

3-39-15, Showa-machi, Maebashi, Gunma, Japan

+81-27-220-8224

akimura@gunma-u.ac.jp

Complete

Oct. 01, 2017

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

prevention purpose

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.

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.

Both

Gastric cancer

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.

Gastric cancer

The incidence of stomatitis and malnutrition

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

+81-27-220-8740

Mar. 13, 2019

none