Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of CIN
Not Applicable
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Interventions
- Registration Number
- NCT02970643
- Lead Sponsor
- Hee Jun Kim
- Brief Summary
The purpose of this study is to determine whether Palonosetron and Olanzapine without dexamethasone for the Prevention of moderate risk Chemotherapy-Induced Nausea and vomiting.
- Detailed Description
This study was designed to evaluate efficacy and safety of olanzapine compared with 5-hydroxytryptamine3 receptor antagonist for prevention of moderate risk chemotherapy induced nausea and vomiting.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- no severe cognitive compromise
- Moderate risk chemotherapy induced chemotherapy induced nausea and vomiting in 1st cycle
- Confirmed histology
Exclusion Criteria
- European Cooperative Oncology Group (ECOG) performance status of 3 and 4
- Nausea or vomiting in the 24 hours before enrollment
- History of Nausea or vomiting Grade 3 before previous chemotherapy
- Known history of central nervous system disease (e.g., brain metastases or a seizure disorder)
- Bowel obstruction
- Serum creatinine level of 2.0 mg per deciliter (177 μmol per liter) or more
- Aspartate or alanine aminotransferase level that was more than 3 times the upper limit of the normal range
- Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment
- Treatment with another antiemetic agent before 48 hours before enrollment
- Uncontrolled severe infection or uncontrolled severe comorbidity
- Concurrent abdominal radiotherapy
- Known hypersensitivity to olanzapine, palonosetron
- Known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 month
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Olanzapine group Olanzapine Palonosetron and Olanzapine Without Dexamethasone in moderate risk chemotherapy induced nausea and vomiting group Olanzapine group Palonosetron Palonosetron and Olanzapine Without Dexamethasone in moderate risk chemotherapy induced nausea and vomiting group
- Primary Outcome Measures
Name Time Method Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 4.0 nausea the overall assessment period (0 to 72 hours)
- Secondary Outcome Measures
Name Time Method Quality of life was evaluated according to MDASI-K the overall assessment period (0 to 72 hours)