Study of NK1-receptor antagonist; aprepitant for prevention of nausea and emesis in patients receiving chemotherapy with irinotecan for gastric cancer.
Not Applicable
Recruiting
- Conditions
- Advanced gastric cancer
- Registration Number
- JPRN-UMIN000011962
- Lead Sponsor
- Gastroenterologic Surgery, Kanazawa University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria
Not provided
Exclusion Criteria
1) patients with serious hepatic insufficiency or renal failure. 2) patients with emesis within 24 hours before first administrating of cisplatin. 3) patients who were administered antiemetic drugs within 48 hours before first administrating of cisplatin. 4) patients with emetic factor except for chemotherapy 5) patient who was intended radiation therapy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ratio of complete response (defined as no emesis and no rescue treatment). [Time Frame: overall; 0-120hr after chemotherapy, acute phase; 0-24hr, delayed phase; 24-120hr].
- Secondary Outcome Measures
Name Time Method 1) ratio of patient without emesis. 2) ratio of patient without rescue treatment. 3) ratio of patient without nausea. 4) time to first emesis. 5) evaluation of volume of meal intake. 6) evaluation of QOL with Functional Living index-Emesis (FLIE) scale.