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.
olanzapine: Administered as 5 mg orally once daily at bedtime, Days 1-3, for delayed-phase antiemetic prophylaxis.
Dexamethasone: Administered as 4 mg orally twice daily (total 8 mg/day), Days 1-3, for delayed-phase antiemetic prophylaxis.
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Complete response during the delayed phase chemotherapy-Induced Nausea and Vomiting (CINV) — 24-120 hours after initiation of AC chemotherapy (Day 0) Proportion of patients with no emetic episodes and no use of rescue antiemetic medication during the delayed phase, comparing the olanzapine-based dexamethasone-sparing regimen (Arm A) to the standard dexamethasone-containing regimen (Arm B).
Total Control during the delayed phase — 24-120 hours after initiation of AC chemotherapy (Day 0) Proportion of patients with no emetic episodes, no use of rescue antiemetic medication, and no nausea during the delayed phase, comparing the two treatment arms.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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