A double-blind randomized controlled trial comparing 0.75mg of Palonosetron with 1mg of Granisetron for the control of highly emetogenic chemotherapy-induced emesis.
- Conditions
- Malignant tumor (lung cancer,gastric cancer,esophagus cancer,cervical cancer,endometrial cancer,head and neck cancer,etc)
- Registration Number
- JPRN-UMIN000004863
- Lead Sponsor
- Pharma Valley Center,Shizuoka Organization for Creation Industries
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 840
Not provided
(1)known prior severe hypersensitivity to 5HT3 receptor antagonist, corticosteroids and aprepitant (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)patients with obstruction of gastrointestinal tract,for example gastric outlet or ileus etc (7)pregnant, breastfeeding or expecting woman (8)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 (9)patients who take a medicine regularly ,for example , 5HT3 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers,antihistamine drugs, benzodiazepine,agents, etc (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 120hours from cisplatin administration
- Secondary Outcome Measures
Name Time Method 1.complete control rate of events associated with vomiting within 120hours from cisplatin administrated 2.total control rate of nausea and vomiting within 120hours from cisplatin administrated 3.time to treatment failure:TTF 4.adverse event