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

Hee Jun Kim

Status: Unknown

Conditions: Chemotherapy-induced Nausea and Vomiting

Treatments: Drug: Palonosetron; Drug: Olanzapine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02970643

C2016034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Olanzapine group

Experimental group

Description:

Palonosetron and Olanzapine Without Dexamethasone in moderate risk chemotherapy induced nausea and vomiting group

Treatment:

Drug: Olanzapine

Drug: Palonosetron