Individualised Versus Standard Care for Breast Cancer Patients at High-risk for Chemotherapy-induced Nausea and Vomiting The ILIAD Study
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, Breast Carcinoma, Breast Tumors, Chemotherapy, Antiemetic effects, Antiemetic drugs, Drug Therapy
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed invasive breast cancer (stage I-III) scheduled to receive neo/adjuvant anthracycline/cyclophosphamide or platinum-based chemotherapy
- ≥18 years
- Able to provide consent and complete all study-related diaries and questionnaires.
Exclusion Criteria:
- Received previous chemotherapy
- Symptoms of nausea or vomiting at baseline
- On chronic antiemetic therapy (e.g. metoclopramide); on daily long term oral steroids prior to chemotherapy
- Allergic or having a medical condition that makes the administration of olanzapine, aprepitant, 5-HT3 antagonists or dexamethasone contraindicated
- Uncontrolled diabetes
- Known/documented medical/psychiatric illness that would interfere with patients' ability to complete the diary and study-related questionnaires.
Sites / Locations
- The Ottawa Hospital Research Institute Cance Center
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo Comparator
Olanzapine
Eligible patients at high personal risk of CIVN will receive Standard of Care Regimen: Aprepitant (125 mg PO OD day 1, 80mg OD days 2-3), ondansetron (8mg PO, BID on Day 1 of each cycle), dexamethasone (12 mg IV x1 before chemotherapy and 4mg PO BID days 2-3) and olanzapine placebo (PO OD days 1-4). Eligible patients at low personal risk of CIVN will receive Standard of Care Regimen: Ondansetron (8mg PO, BID on Day 1 of each cycle,), dexamethasone (12 mg IV x1 before chemotherapy and 4mg PO BID days 2-3) and olanzapine placebo (PO OD days 1-4).
Eligible patients at high personal risk of CIVN will receive Standard of Care Regimen: Aprepitant (125 mg PO, OD day 1, 80mg OD days 2-3), ondansetron (8mg PO, BID on Day 1 of each cycle), dexamethasone (12 mg IV x1 before chemotherapy and 4mg PO BID days 2-3) and olanzapine (5 mg PO OD days 1-4). Eligible patients at low personal risk of CIVN will receive Standard of Care Regimen: Ondansetron (8mg PO, BID on Day 1 of each cycle), dexamethasone (12 mg IV x1 before chemotherapy and 4mg PO BID days 2-3) and olanzapine (5 mg PO OD days 1-4).