Olanzapine and 5-HT3 With or Without Dexamethasone to Prevent CINV

May 29, 2025 updated by: Xingchen Peng

Olanzapine and 5-HT3 With or Without Dexamethasone to Prevent Nausea and Vomiting Induced by Chemotherapy: A Non-inferiority, Prospective, Multi-Centered, Randomized, Controlled, Phase III Clinical Trial

Nausea and vomiting caused by chemotherapy are considered by patients as the main side effects of cancer treatment, which affect the quality of treatment and life.At present, NCCN guidelines have recommended three or four drug regimens for highly emetic chemotherapy (HEC) to prevent vomiting, all containing dexamethasone.However, its side effects such as moderate to severe insomnia, hyperglycemia, dyspepsia, upper abdominal discomfort, irritability, increased appetite, weight gain and acne are gathering increasing concerns.For certain patients, the use of dexamethasone should be avoided.Analysis shows that olanzapine can replace the effect of dexamethasone.Hence, the investigators initiated this prospective, multi-center, phase III study to validate the dexamethasone-free protocol: removing dexamethasone from a three drug regimen containing olanzapine, dexamethasone, and 5-HT3RA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

275

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients 18 years of age or older with malignant disease；
  2. Life expectancy ≥ 3 months;
  3. Scheduled to receive highly emetogenic chemotherapy；
  4. Had a European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Exclusion Criteria:

  1. There are contraindications to chemotherapy(Absolute number of neutrophils ≤ 1,500/uL, hemoglobin ≤ 90g/L, platelet count ≤ 10000/uL, serum creatinine level ≥ 2.0mg/dl (177 μmol/L), ALT and AST ≥ 2.5 times the upper normal limit, bilirubin ≥ 1.5 times the upper normal limit);
  2. History of central nervous system disease (e.g., brain metastases or a seizure disorder);
  3. Severe cognitive impairment；
  4. Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period;
  5. Concurrent use of pharyngeal or abdominal radiotherapy;
  6. Concurrent use of quinolone antibiotics;
  7. Concurrent use of Amifostine;
  8. Chronic alcoholism;
  9. Known hypersensitivity to olanzapine;
  10. Know arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within 6 months;
  11. Known uncontrolled diabetes mellitus;
  12. Vomiting or retching 24 hours before chemotherapy;
  13. Use of anti-emesis drugs 48 hours before chemotherapy;
  14. Patients who require medication with dexamethasone for pretreatment.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5HT3RA+Olanzapine
Using one of the 5-HT3 receptor antagonists within 30 minutes before cisplatin/adriamycin/cyclophosphamide.On day 1-4, Olanzapine is delivered orally after dinner.
Drug: 5HT3RA+Olanzapine

Using one of the 5-HT3 receptor antagonists within 30 minutes before cisplatin/adriamycin/cyclophosphamide.

On day 1-4, Olanzapine is delivered orally after dinner.
Active Comparator: 5HT3RA+Olanzapine+Dexamethasone
Using one of the 5-HT3 receptor antagonists within 30 minutes before cisplatin/adriamycin/cyclophosphamide.On day 1-4, Olanzapine is delivered orally after dinner.On first day, dexamethasone is given orally within 30 minutes before cisplatin/adriamycin/cyclophosphamide administered.
Drug: 5HT3RA+Olanzapine+Dexamethasone

Using one of the 5-HT3 receptor antagonists within 30 minutes before cisplatin/adriamycin/cyclophosphamide.

On day 1-4, Olanzapine is delivered orally after dinner. On first day, dexamethasone is given orally within 30 minutes before cisplatin/adriamycin/cyclophosphamide administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
0-120h Complete Remission Rate
Time Frame: 24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy
The ratio of patients who have no vomiting and apply no anti-nausea drugs during the whole observation period.
24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
0-120h No Nausea Rate
Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy
The ratio of patients who have no nausea during the whole observation period.
24 hours, 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy
25-120 hours Complete Remission Rate
Time Frame: 24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy
The ratio of patients who have no vomiting and apply no anti-nausea drugs during the 25-120 hours observation period.
24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy

Collaborators and Investigators

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

Sponsor

Xingchen Peng

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)

April 15, 2023

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

May 15, 2024

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 10, 2023

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

May 29, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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