Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of CIN

Study Overview
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Brief Summary
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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
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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.

Official Title
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Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting

Conditions
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Chemotherapy-induced Nausea and Vomiting

Intervention / Treatment
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* Drug: Olanzapine
* Drug: Palonosetron


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olanzapine group<br>Palonosetron and Olanzapine Without Dexamethasone in moderate risk chemotherapy induced nausea and vomiting group | Drug: Olanzapine<br>* Moderate risk chemotherapy induced nausea group in all cancer. D1 Olanzapine 10mg PO D2-3 Olanzapine 10mg PO<br>* Other names: Zyprexa;Drug: Palonosetron<br>* Moderate risk chemotherapy induced nausea group in all cancer. D1 Palonosetron 0.25mg IV<br>* Other names: Aloxi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life was evaluated according to MDASI-K |  | the overall assessment period (0 to 72 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Olanzapine, Chemotherapy-Induced Nausea and Vomiting, Moderate risk