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Olanzapine Based Dexamethasone-sparing Regimen for Breast Cancer Patients With Metabolic-risk Factors

NCT07743827 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-08-04

No results posted yet for this study

Summary

The aim of THE STUDY to determine whether an olanzapine-based dexamethasone-sparing antiemetic regimen is non-inferior to the standard dexamethasone-containing regimen in preventing delayed-phase Chemotherapy-induced nausea and vomiting while reducing metabolic toxicity in breast cancer patients with metabolic risk factors.

Conditions

Interventions

DRUG

Pantoprazole

Administered as 40 mg orally once daily on Days 1 to 3 (1 hour before breakfast) in both arms as standard gastroprotective co-medication to prevent chemotherapy- and corticosteroid-induced gastritis and dyspepsia.

DRUG

olanzapine

Administered as 5 mg orally once daily at bedtime, Days 1-3, for delayed-phase antiemetic prophylaxis.

DRUG

Dexamethasone

Administered as 4 mg orally twice daily (total 8 mg/day), Days 1-3, for delayed-phase antiemetic prophylaxis.

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-05-10
Primary Completion
2027-09-29
Completion
2027-10-15

Countries

  • Egypt

Study Locations

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Entities

Drugs
Diseases

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 NCT07743827 on ClinicalTrials.gov