A single-blind randomized controlled trial comparing Aprepitant plus (Granisetron)1st 5-HT3 receptor antagonist and Palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapies including CBDCA in the gynecology cancer patients.
- Conditions
- Patients with gynecologic cancer receiving chemotherapy including carboplatin (that is, TC therapy: carboplatin + paclitaxel)
- Registration Number
- JPRN-UMIN000008552
- Lead Sponsor
- St. Mariannna University, School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 300
Not provided
1. Patients complicated with serious hepatic disorders or renal disorders. 2. Patients with nausea and vomiting within 24 hours before initiation of cancer chemotherapy. 3. Patients who used an antiemetic agent within 48 hours before initiation of cancer treatment. 4. Patients with nausea and vomiting due to causes (brain tumor, digestive passage disorders, active peptic ulcer, brain metastasis, use of opioids, etc.) other than cancer chemotherapy. 5. Patients with an associated disease, including uncontrolled diabetes, that prevents administration of dexamethasone for three days. 6. Patients under medication with pimozide. 7. Patients for whom abdominal radiotherapy is planned. 8. Patients with a history of vomiting in past chemotherapy. 9. Patients judged to be inappropriate for the study by the physician in charge.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint was the percentage of patients with a complete response (no vomiting and no salvage treatment) throughout the first course of chemotherapy.
- Secondary Outcome Measures
Name Time Method