A Phase II Study of Olanzapine, Palonosetron and Dexamethasone for nausea and vomiting induced by the highly emetic chemotherapy including Cisplati
- Conditions
- Malignant tumor (lung cancer, gastric cancer, esophagus cancer, cervical cancer, endometrial cancer, head and neck cancer, etc)
- Registration Number
- JPRN-UMIN000013482
- Lead Sponsor
- Aichi Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 41
Not provided
(1) known prior severe hypersensitivity (2) patients who do not have enough whole body state to the antineoplastic agents treatment (3) known symptomatic brain metastasis (4) patients who has a convulsive disorders that need anticonvulsants therapy (5) patients with a symptom who has ascites or pleural effusion that need puncture (6) pregnant, breastfeeding or expecting woman (7) patients enforced radiotherapy at the bottom of diaphragm on the period between 6 days before and 6 days after of the date of first therapy (8) patients who take a medicine regularly ,for example , 5HT3 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers,antihistamine drugs, benzodiazepine,agents, etc (9) patients who can not hospitalize during 120 hours from cisplatin administration (10) judged by the investigator to be inappropriate for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response rate of vomiting within 120 hours from cisplatin administration
- Secondary Outcome Measures
Name Time Method 1)Total control rate of nausea and vomiting within 120hours from cisplatin administration 2)adverse event