Olanzapine Based Dexamethasone-sparing Regimen for Breast Cancer Patients With Metabolic-risk Factors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorAlexandria University
About this trial
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 criteria
Qualifiers
Female patients ≥18 years.
Stage I-III breast cancer.
Scheduled to receive AC chemotherapy.
Presence of metabolic risk factors (diabetes, prediabetes, obesity, metabolic syndrome).
Disqualifiers
Recent systemic corticosteroid use.
Active nausea or vomiting before chemotherapy.
Severe renal or hepatic impairment.
Uncontrolled diabetes or hypertension.
Trial design
Treatments tested in this trial
- Pantoprazole
- olanzapine
- Dexamethasone
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov