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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02970643

Enrollment

Registered

2016-11-22

Start date

2016-07-31

Completion date

2017-12-31

Last updated

2016-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-induced Nausea and Vomiting

Keywords

Olanzapine, Chemotherapy-Induced Nausea and Vomiting, Moderate risk

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.

Interventions

DRUGOlanzapine

Moderate risk chemotherapy induced nausea group in all cancer. D1 Olanzapine 10mg PO D2-3 Olanzapine 10mg PO

DRUGPalonosetron

Moderate risk chemotherapy induced nausea group in all cancer. D1 Palonosetron 0.25mg IV

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026