Olanzapine-based, dexamethasone-sparing antiemetic regimen for breast cancer patients with metabolic risk factors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial compares an olanzapine-based antiemetic regimen to the standard dexamethasone-containing regimen in women with stage I–III breast cancer receiving highly emetogenic AC chemotherapy and who have metabolic risk factors. The goal is to see if the olanzapine approach is non-inferior for preventing delayed-phase nausea and vomiting while reducing metabolic toxicity. The regimen includes pantoprazole, olanzapine, and dexamethasone as components of antiemetic prophylaxis. The study addresses persistent delayed emesis in a population at higher metabolic risk and explores multi-receptor antiemetic strategies. Outcomes likely focus on nausea/vomiting control, safety, and metabolic profiles.

Why it matters

Who can join: the full rules

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

Where it's running

• Alexandria Main University Hospital
  Alexandria, Alexandria Governorate, Egypt Recruiting

Study contacts

• Study coordinator: mohamed younes, B.pharmacy
• Email: mohamedyounes93ly@gmail.com
• Phone: +201500993053

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.