Feasibility study to evaluate the efficacy of elemental diet in metastatic or advanced gastric cancer patients treated with chemotherapy.

Not Applicable

• Conditions: metastatic or advanced gastric cancer

• Registration Number: JPRN-UMIN000007814
• Lead Sponsor: PO Hokkaido Gastrointestinal Cancer Study Group (HGCSG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-02
• Study Completion: 2016-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Patients who recieved nutritional therapy for one week or more within the past two months (2) Patient who took L-glutamine quantity content drugs (marzulene, GFO, etc.) for less than two weeks of past. (3) Patients who are associated with uncontrollable abnormal glucose tolerance (4) Patients who are associated with critical complications (5) Pregnancy and lactation, and/or without intention of birth control. (6) Patients with mental disorders (7) Patients applicable to contraindications of each use drugs. (8) Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Treatment Failure

Secondary Outcome Measures

Name	Time	Method
1) Incidence of adverse events (particularly stomatitis incidences, diarrhoea incidence, etc.), 2) Body weight change, 3) Serum albumin change, 4) Relative dose intensity, 5) Safety, 6) Compliance of elemental diet, 7) The number of first-line cycles, 8) response of the tumor, 9) Progression free survival, 10) Overall survival