Study of efficacy and safety of oral neurokinin-1 antagonist, aprepitant for prevention of chemotherapy-induced nausea and vomiting associated with 5-FU/cisplatin chemotherapy in patients with head and neck cancer.
Not Applicable
- Conditions
- head and neck cancer
- Registration Number
- JPRN-UMIN000005071
- Lead Sponsor
- Department of otolaryngology , Nagasaki University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patient has a serious hepatic insufficiency or renal failure 2) Patient has nausea or vomiting within 24 hours prior to chemotherapy 3) Patient has been treated with antiemetic agents within 48 hours prior to chemotherapy 4) Patient has any illness (e.g. central nervous system tumors, gastrointestinal obstruction, active peptic ulcer, brain metastasis) caused nausea or vomiting except for chemotherapy-induced nausea and vomiting 5) Patient is scheduled to receive radiation therapy to the abdomen 6) Patient is judged inappropriate by the investigator as subject for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients with Complete Response (no vomiting and no use of rescue therapy) in overall phase (8 days after administration of cisplatin on day 1)
- Secondary Outcome Measures
Name Time Method 1) The proportion of patients with Complete Response in acute phase (days 1 to 4 after administration of cisplatin on day 1) and delayed phase (days 5 to 8 after administration of cisplatin on day 1) 2) The proportion of patients with no vomiting in overall, acute, and delayed phase 3) The frequency of nausea and vomiting 4) Food Intake