Olanzapine Based Dexamethasone-sparing Regimen for Breast Cancer Patients With Metabolic-risk Factors
Recruiting · NCT07743827 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Alexandria Main University Hospital - Alexandria, Alexandria Governorate, Egypt