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Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients

NCT04503668 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-06-18

Study results available
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Summary

The objective of this study is to investigate the efficacy of olanzapine as compared to neurokinin-1 receptor antagonists (NK1-RAs) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic malignancies receiving single day outpatient chemotherapy (carboplatin and paclitaxel) every 3 weeks.

Conditions

  • Gynecologic Cancer

Interventions

DRUG

Ondansetron

8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy

DRUG

Dexamethasone

20 mg IV on day 1 pre-chemotherapy

DRUG

Neurokinin-1 Receptor Antagonist (NK1-RA)

150 mg IV on day 1 pre-chemotherapy

DRUG

Olanzapine

5 mg by mouth on days 1-4 of chemotherapy (taken at night)

DRUG

Compazine

5-10 mg by mouth, available as needed, every 6 hours, days 1-5

Sponsors & Collaborators

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Aimee Rolston · University of Michigan Rogel Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-28
Primary Completion
2024-01-03
Completion
2024-03-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04503668 on ClinicalTrials.gov