Phase2 study of palonosetoron and dexamethasone therapy for prevention of carboplatin-induced nausea and vomiting in patients with gynecological cancer.
- Conditions
- gynecological cancer (ovarian cancer, endometrial cancer and uterine cervix cancer)
- Registration Number
- JPRN-UMIN000012806
- Lead Sponsor
- West Japan Gynecologic Oncology Group
- Brief Summary
While palonosetron effectively controls acute CINV, additional antiemetic management is warranted in the delayed phase after carboplatin-based chemotherapy in gynecologic cancer patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 80
Not provided
1 Uncontrolled severe complication disease without cancers 2 Symptomatic brain metastasis 3 Epilepsy patient treated with antiepileptic agent, excluding being 4 Patient with massive pleural effusion or ascites to be required drainage 5 Intestinal paralysis or ileus 6 Grade 2 or more nausea and vomiting 7 Hypersensitivity for palonosetron and other 5 HT3 antagonist 8 Hypersensitivity for dexamethasone 9 Pregnant ,lactating woman or women who do not agree that we prevent conception 10 Patient with history of palonosetoron treatment 11 Patient without compliance of this study rule 12 Other patients who are unfit for the study as determined by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method