Steroid Sparing Regimen With Olanzapine and Palonosetron for Emetic Prevention for High Dose Cisplatin

July 7, 2026 updated by: Mahidol University

Steroid-sparing Regimen With Olanzapine and Ondansetron to Prevent Emesis Caused by High Dose Cisplatin in Solid Cancer Patient : A Single Arm Phase II Study

A phase II study evaluating dexamethasone sparing regimen with olanzapine and palonosetron for patients receiving high dose cisplatin to prevent chemotherapy induced nausea and vomiting

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

95

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital, Mahidol University
        • Contact:
        • Sub-Investigator:
          • Akarin Nimmannit, M.D
        • Principal Investigator:
          • Sirisopa Techawattanawanna, M.D
        • Sub-Investigator:
          • Visullaya Sa-nguanwongwan, M.D

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • histologically confirmed solid malignancy
  • scheduled for first cycle of cisplatin at dosage of at least 50 mg/m2

Exclusion Criteria:

  • pregnancy
  • pelvic or abdominal radiation within 4 weeks
  • uncontrolled brain metastasis
  • other moderate or high emetic risk chemotherapy on day 2-5
  • untreated gut obstruction
  • known allergy or severe adverse effect from palonosetron or olanzapine
  • AST/ ALT > 2.5x or serum creatinine clearance less than 50 ml/min

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: study arm
olanzapine palonosetron with dexamethasone on day 1 only
Drug: dexamethasone sparing
omit dexamethasone on day 2-4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete response rate
Time Frame: 5 days after receiving chemotherapy
no vomiting and no rescue therapy
5 days after receiving chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
no -nausea rate
Time Frame: 5 days after receiving chemotherapy
no nausea symptom
5 days after receiving chemotherapy
degree of nausea vomiting
Time Frame: 5 days after receiving chemotherapy
grading of nausea vomiting
5 days after receiving chemotherapy
adverse effects
Time Frame: 5 days after receiving chemotherapy
adverse effects
5 days after receiving chemotherapy
rescue therapy
Time Frame: 5 days after chemotherapy
additional treatment for nausea or vomiting
5 days after chemotherapy

Collaborators and Investigators

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

Sponsor

Mahidol University

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 (Actual)

February 10, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 15, 2027

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 330/2568(IRB4)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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