open label, randomized, pilot study on the activity of olanzapine with or without delayed dexamenthasone versus dexamenthasone alone for the prevention of delayed nausea and vomiting in patients with gynecologic cancers receiving carboplatin and paclitaxel-based chemotherapy and guidline-directed prophylactic anti-emetics
Phase 1
- Conditions
- Patients with gynecologic tumors candidate to chemotherapy with carboplatinum and paclitaxelTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-005309-30-IT
- Lead Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 75
Inclusion Criteria
patient with diagnosis of gynecologic cancer not pretreate with chemoterapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
Exclusion Criteria
patients scheduled to receive chemotherapy, brain metastases, patients who receive another antipsychotic agent, performance status >2
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method