A phase II study of aprepitant, palonosetron, dexamethasone and olanzapine for the prevention of cisplatin-based hemotherapy-induced nausea and vomiting for thoracic malignancy
- Conditions
- Thoracic malignancy
- Registration Number
- JPRN-UMIN000017486
- Lead Sponsor
- Shizuoka cancer center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1) Prior severe hypersensitivity to aprepitant, 5HT3 receptor antagonist, corticosteroids or olanzapine 2) Patients who do not have enough whole body state to the antineoplastic agents treatment 3) Severe complication 4) Patients who have conceived child or desire childbearing or breast-feed their baby 5) 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 6) Patients who cannot stay in hospital till the 6th day of chemotherapy 7) HbA1c (NGSP) >= 6.5. FBS >= 126mg/dl or BS >= 200mg/dl 8) Diabetes mellitus 9) Patient with nausea and vomiting needing for medical treatment beore chemotherapy 10) Patient who have previous history or familial history of malignant syndrome 11) CK more than 2.5 times of institutional upper normal limit 12) Patients with active infection 13) Patient who cannot stop smoking during this study 14) BMI (body mass index) >= 35 15) Patients who take a medicine regularly ,for example , 5HT3 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers,antihistamine drugs, benzodiazepine,agents, etc
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of patients with complete response (no emetic episodes and no use of rescue medication) for the overall period (0-120h post-administration of cisplatin)
- Secondary Outcome Measures
Name Time Method (1) The percentage of patients with complete response for the acute period (0-24h post-administration of cisplatin) and the delayed period (24-120h post-administration of cisplatin) (2) The percentage of patients with complete control (no emetic episodes, no use of rescue medication, and no more than mild nausea) for the acute period, the delayed period, and the overall period (3) The percentage of patients with total control (no emetic episodes, no use of rescue medication, and no nausea) for the acute period, the delayed period, and the overall period (4) Adverse events