Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy

Summary

Breakthrough chemotherapy-induced vomiting (CIV) is defined as CIV occurring after adequate antiemetic prophylaxis. Olanzapine is recommended for the treatment of breakthrough CIV in children, without adequate evidence. We conducted an open-label, single-center, phase 3 randomized controlled trial comparing the safety and efficacy of olanzapine and metoclopramide for treating breakthrough CIV.

Timeline

Start

2025-07-01

Primary completion

2026-06-30

Completion

2026-07-30

Publications

• Results Radhakrishnan V, Pai V, Rajaraman S, Mehra N, Ganesan T, Dhanushkodi M, Perumal Kalaiyarasi J, Rajan AK, Selvarajan G, Ranganathan R, Karunakaran P, Sagar TG. Olanzapine versus metoclopramide for the treatment of breakthrough chemotherapy-induced vomiting in children: An open-label, randomized phase 3 trial. Pediatr Blood Cancer. 2020 Sep;67(9):e28532. doi: 10.1002/pbc.28532. Epub 2020 Jun 22.
• Results Moshayedi M, Salehifar E, Karami H, Hendouei N, Mousazadeh M, Alizadeh Haji S. Efficacy and Safety of Adding Olanzapine to the Standard Preventive Regimen for Chemotherapy-induced Nausea and Vomiting in Children: A Randomized Double-blind Controlled Trial. Iran J Pharm Res. 2021 Winter;20(1):318-326. doi: 10.22037/ijpr.2019.112514.13803.
• Results Meena JP, Gupta AK, Jat KR, Anandani G, Sasidharan A, Tanwar P. Efficacy and Safety of Olanzapine for the Prevention of Chemotherapy-induced Nausea and Vomiting in Children: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Pediatr Hematol Oncol. 2023 Oct 1;45(7):361-369. doi: 10.1097/MPH.0000000000002737. Epub 2023 Aug 3.
• Results Yoodee J, Permsuwan U, Nimworapan M. Efficacy and safety of olanzapine for the prevention of chemotherapy-induced nausea and vomiting: A systematic review and meta-analysis. Crit Rev Oncol Hematol. 2017 Apr;112:113-125. doi: 10.1016/j.critrevonc.2017.02.017. Epub 2017 Feb 20.
• Results Chiu L, Chow R, Popovic M, Navari RM, Shumway NM, Chiu N, Lam H, Milakovic M, Pasetka M, Vuong S, Chow E, DeAngelis C. Efficacy of olanzapine for the prophylaxis and rescue of chemotherapy-induced nausea and vomiting (CINV): a systematic review and meta-analysis. Support Care Cancer. 2016 May;24(5):2381-2392. doi: 10.1007/s00520-016-3075-8. Epub 2016 Jan 15.
• Results Naik RD, V S, Singh V, Pillai AS, Dhawan D, Bakhshi S. Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy: Investigator-Initiated, Randomized, Open-Label Trial. J Clin Oncol. 2020 Nov 10;38(32):3785-3793. doi: 10.1200/JCO.20.00871. Epub 2020 Sep 15.
• Results Sutherland A, Naessens K, Plugge E, Ware L, Head K, Burton MJ, Wee B. Olanzapine for the prevention and treatment of cancer-related nausea and vomiting in adults. Cochrane Database Syst Rev. 2018 Sep 21;9(9):CD012555. doi: 10.1002/14651858.CD012555.pub2.

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