Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Olanzapine as add-on antiemetic prophylaxis: Olanzapine 5 mg administered orally once daily from Day 1 to Day 5 of chemotherapy, in addition to standard guideline-based antiemetic proph
Sponsors
All India Institute of Medical Sciences (AIIMS)- Bibinagar
Eligibility
Inclusion criteria
Inclusion criteria: Biopsy proven solid tumors planned for single MEC regimen with ECOG 0-1 who provide written informed consent.
Exclusion criteria
Exclusion criteria: Vomiting or moderate/severe nausea within 24 hours before chemotherapy. Known hypersensitivity to olanzapine, palonosetron,aprepitant/fosaprepitant, or dexamethasone. Concurrent use of strong sedatives/antipsychotics that cannot be withheld. Uncontrolled diabetes, unstable cardiac disease, uncontrolled infection, or significant hepatic impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response (CR) during 0 120 hours: defined as no vomiting, no use of rescue medication, and nausea VAS scoring of 0. Timepoint: Complete Response (CR) during 0 120 hours: defined as no vomiting, no use of rescue medication, and nausea VAS scoring of 0. | — |
Secondary
| Measure | Time frame |
|---|---|
| CR in acute phase (0 24 hours) & delayed phase (25 120 hours).Timepoint: 1 day & 5 days;Use & amount of rescue antiemetic medicationTimepoint: 5 days;Change in FLIE score from baseline to day 7 10; proportion with FLIE indicating no functional impairment.Timepoint: Day 0 & Day 7;Incidence & severity of adverse events (CTCAE v5.0), with emphasis on somnolence, constipation, appetite change, extrapyramidal symptoms, & metabolic signals. Timepoint: 5 days;Subgroup responses by regimen type (oxaliplatin vs carboplatin vs irinotecan). Timepoint: 5 days | — |
Countries
India
Contacts
Public ContactAjay Kumar Kondeti
All India Institute of Medical Sciences (AIIMS), Bibinagar, Hyderabad, India
Outcome results
None listed