Abstract 593TiP
Background
Chemotherapy-induced nausea and vomiting (CINV) are common and disturbing side effects and without proper therapy, the risk rises to 90 % of patients with highly-emetogenic-chemotherapy (HEC). The ASCO and NCCN guidelines recommend olanzapine as a first-choice option in combination with standard triplet regimen for patients receiving HEC as a new quadruple standard antiemetic regimen. Despite the quadruple drug prophylaxis, delayed nausea- vomiting, significantly impacts the patient’s outcomes and the AEs of olanzapine are troublesome. Hence, the need for a better alternative. Mirtazapine, in addition to its antiemetic effects, accelerates gastric emptying, stimulates appetite, improves sleep quality and has anxiolytic properties. Studies comparing Mirtazapine and Olanzapine in terms of efficacy and tolerability in CINV of HEC are few. Hence, the present study will be conducted to compare the antiemetic prophylaxis and safety of Mirtazapine versus olanzapine (both in combination with triplet regimen) receiving first dose of highly emetogenic chemotherapy regimens during acute phase (0-24 hours), delayed phase (24-120 hours) and overall period (0-120 hours).
Trial design
Prospective, open label, randomized controlled trial to enrol 120 chemotherapy naive patients (60 in each group) requiring HEC. Baseline data will be collected. Block randomization technique and opaque numbered envelopes will be used for allocation. Patients to keep a diary record of emetic episodes, nausea, use of rescue medications, occurrence of Adverse Events (AE) and to fill the FLIE questionnaire on Day 2 and Day 6 and responses will be collected on D6. Proportion of patients with nausea, vomiting and need of rescue medication during acute, delayed and overall period in both the study groups will be analyzed. Table: 593TiP
Treatment arms
| ARM | Drug | Days |
| ARM A (FDP-M) | INJ FOSAPREPITANT 150mg IV | Day1 |
| INJ DEXAMETHASONE 8-12mg IV followed by | Day1 | |
| TAB DEXAMETHASONE 4mg BD | Day 1-4 | |
| INJ PALONOSETRON 0.25mg IV | Day 1 | |
| TAB MIRTAZAPINE 15mg OD | Day 1-4 | |
| ARM B (FDP-O) | INJ FOSAPREPITANT 150mg IV | Day1 |
| INJ DEXAMETHASONE 8-12mg IV followed by | Day1 | |
| TAB DEXAMETHASONE 4mg BD | Day 1-4 | |
| INJ PALONOSETRON 0.25mg IV | Day 1 | |
| TAB OLANZAPINE 5mg OD | Day 1-4 |
Clinical trial identification
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.