A Randomized Study of Olanzapine for the Prevention of CINV in Patients Receiving Moderately Emetogenic Chemotherapy
- Registration Number
- NCT02400866
- Lead Sponsor
- Korean South West Oncology Group
- Brief Summary
This aim of study is to evaluate the safety and efficacy of olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy by a randomized, double-blind, placebo-controlled trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 58
Inclusion Criteria
- over 19 years of age
- no history of receiving moderately or highly emetogenic chemotherapy during last 6 months, and is to receive a first course of MEC including one or more of following agents: Carboplatin, Cyclophosphamide ≤ 1,500 mg/m2, Daunorubicin, Doxorubicin < 60 mg/m2, Epirubicin ≤ 90 mg/m2, Irinotecan, Oxaliplatin, Melphalan, Methotrexate ≥ 250 mg/m2
- ECOG performance status 0-2
- predicted life expectancy ≥ 3 months
- adequate bone marrow, kidney, and liver functionas evidenced by: ANC ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, total bilirubine ≤ 2 x ULN, AST ≤ 3 x ULN, ALT ≤ 3 x ULN (for subjects with known liver metastases, total bilirubin ≤ 3 x ULN, AST ≤ 5 x ULN, ALT ≤ 5 x ULN), Creatinine ≤ 1.5 x ULN or Ccr ≥ 50 ml/min
- no episodes of nausea and vomiting during last 24 hours before enrollment
- subjects provides written informed consent
Exclusion criteria:
- subjects with uncontrolled neuro-psychiatric disease (alcohol abuse, seizure, psychosis etc) except malignant tumor
- subject is scheduled to receive highly emetogenic chemotherapeutic agents: Doxorubicin or Epirubicin + cyclophosphamide, Cisplatin ≥ 50 mg/m2, Carmustine > 250 mg/m2, Cisplatin ≥ 50 mg/m2, Cyclophosphamide > 1,500 mg/m2, Dacarbazine, Doxurubicine ≥ 60 mg/m2, Epirubicine > 90 mg/m2, Ifosfamide ≥ 2 g/m2 per dose, Mechlorethamine, Streptozocin
- contraindication to the administration of palonosetron, dexamethasone, and olanzapine due to hypersensitivity or any other reasons
- subject has severe cognitive impairment
- subjects has symptomatic or uncontrolled brain metastasis or brain tumor
- female subjects of childbearing potential who dose not agree to use a proper contraceptive methods or to limit breast feeding
- subject has taken the following agents: risperidone, quetiapine, clozapine, phenothiazine, butyrophenone, 5-HT3 antagonist, bezamides, domperidone, cannabinoids, NK1 antagonist, bezodiazepines
- subject has a plan to receive other chemotherapy, abdomial radiation, surgery, or immunotherapy
- any history of arrhythmia, uncontrolled congestive heart failure, acute myocardial infarction durting last 6 months
- history of uncontrolled diabetes
- subject who has used any investigational drugs within 30 days of randomization
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Olanzapine palonosetron + dexamethasone + olanzapine
- Primary Outcome Measures
Name Time Method complete response rate for the acute phase (0-24 hours) after chemotherapy during 24 hours after first cycle of moderately emetogenic chemotherapy (MEC)
- Secondary Outcome Measures
Name Time Method effects on quality of life by FLIE questionnaire during 0-120 hours after first cycle of MEC no vomiting for the overall phase during 0-120 hours after first cycle of MEC complete response rate for the delayed phase (24-120 hours) and overall phase (0-120 hours) after chemotherapy during 0-120 hours after first cycle of MEC numbers and time for rescue medicaions during 0-120 hours after first cycle of MEC significant emesis for the overall phase during 0-120 hours after first cycle of MEC