Study of efficacy and tolerability of combination therapy with palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with cervical cancer.
- Conditions
- Cervical cancer
- Registration Number
- JPRN-UMIN000004962
- Lead Sponsor
- Kyoto University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 40
Not provided
# They had serious complication. (intestinal paralysis, lung fibrosis, diabetes mellitus, heart failure, myocardial infarction, angina pectoris, renal failure, psychiatric disorder, cerebrovascular accident, active gastric ulcer, active duodenal ulcer) # No known CNS metastasis # Patients who has a convulsive disorders that need anticonvulsants therapy # They had ascites or pleural effusion needs paracentesis treatment # Patients with obstruction of gastrointestinal tract,for example gastric outlet or ileus # Patients with vomiting or nausea (>= Grade2) # Hypersensitivity or severe drug allergy for Aloxi or other 5-HT3RA # Hypersensitivity or severe drug allergy for dexamethasone # Pregnant, breastfeeding or expecting woman # Patients judged inappropriate for this study by physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients with complete response (CR: no vomiting and no use of rescue therapy ) in the delayed phase (24-120 hour after administration of nedaplatin and irinotecan)
- Secondary Outcome Measures
Name Time Method