Olanzapine Based Dexamethasone-sparing Regimen for Breast Cancer Patients With Metabolic-risk Factors | NCT07743827

NCT07743827

Overview

NCT ID: NCT07743827
Lead Sponsor: Alexandria UniversityOTHER
Official Title: Efficacy of an Olanzapine Based Dexamethasone-sparing Regimen in Breast Cancer Patients With Metabolic-risk Factors: A Randomized, Controlled Trial
Brief 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: Olanzapine
Breast Cancer
Dexamethasone
Interventions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Female patients ≥18 years.

Stage I-III breast cancer.

Scheduled to receive AC chemotherapy.

Presence of metabolic risk factors (diabetes, prediabetes, obesity, metabolic syndrome).

ECOG performance status ≤2.

Exclusion Criteria:

Recent systemic corticosteroid use.

Active nausea or vomiting before chemotherapy.

Severe renal or hepatic impairment.

Uncontrolled diabetes or hypertension.

Psychiatric illness affecting adherence.

Pregnancy or lactation.

Active infections or inflammatory diseases.

Participation in another clinical trial

Central Contacts: mohamed younes, B.pharmacyContact
mohamedyounes93ly@gmail.com

Participant Group/Arms

Olanzapine-Based Dexamethasone-Sparing RegimenExperimental

* Pantoprazole 40 mg PO daily (1 hour before breakfast) * Olanzapine 5 mg PO daily (at bedtime)

Drug: Pantoprazole

Drug: olanzapine

Dexamethasone-Containing Standard RegimenActive Comparator

* Pantoprazole 40 mg PO daily (1 hour before breakfast) * Olanzapine 5 mg PO daily (at bedtime) * Dexamethasone 4 mg PO BID (total 8 mg/day)

Drug: Pantoprazole

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