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

November 22, 2016 updated by: Hee Jun Kim

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: the overall assessment period (0 to 72 hours)
the overall assessment period (0 to 72 hours)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hee Jun Kim

Collaborators

HK inno.N Corporation

Investigators

  • Study Chair: Heejun Kim, MD.PhD, Associate Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

November 21, 2016

First Posted (Estimate)

November 22, 2016

Study Record Updates

Last Update Posted (Estimate)

November 23, 2016

Last Update Submitted That Met QC Criteria

November 22, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C2016034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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