Efficacy of an Olanzapine Based Dexamethasone-sparing Regimen in Breast Cancer Patients With Metabolic-risk Factors: A Randomized, Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Egypt
Alexandria Main University Hospital
RECRUITING
Alexandria
Contact Information
Primary
mohamed younes, B.pharmacy
mohamedyounes93ly@gmail.com
+201500993053
Time Frame
Start Date: 2026-05-10
Estimated Completion Date: 2027-10-15
Participants
Target number of participants: 90
Treatments
Experimental: Olanzapine-Based Dexamethasone-Sparing Regimen
* Pantoprazole 40 mg PO daily (1 hour before breakfast)~* Olanzapine 5 mg PO daily (at bedtime)
Active_comparator: Dexamethasone-Containing Standard Regimen
* 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)
Related Therapeutic Areas
Sponsors
Leads: Alexandria University