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

Официальное название

Olanzapine for the Treatment of Breakthrough Chemotherapy-Induced Vomiting in Children: An Open-label, Randomized Phase 3 Trial

Обзор

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.

Подробное описание

Children aged 5-18 years who developed breakthrough CIV after receiving highly emetogenic chemotherapy were randomly assigned to the control(placebo) or olanzapine arm. The primary objective of the study was to compare the complete response (CR) rates between patients receiving olanzapine or placebo for treating breakthrough CIV during 72 hours after the administration of the study drug. Secondary objectives were to compare CR rates for nausea and toxicities between the two arms.

Вмешательства

• Препарат Olanzapine Tablets
  Oral olanzapine tablets
• Препарат Placebo
  Oral placebo

Первичные конечные точки

• the CR rate for vomiting in the first 72 hours [Срок оценки: in the first 72 hours of the initiation of olanzapine]

Вторичные конечные точки (1)

• the CR rate for nausea in the first 72 hours of the initiation of olanzapine [Срок оценки: in the first 72 hours of the initiation of olanzapine]

Критерии участия

Критерии включения

\- The major inclusion criteria were children aged 5 to 18 years at the time of study entry with documented cancer; receiving NK-1 inhibitor (aprepitant/fosaprepitant) and 5HT-3 antagonist (ondansetron) and/or dexamethasone as prophylactic antiemetics for CINV due to MEC or HEC; minimum body weight of 10 kg; development of breakthrough vomiting after starting prophylactic antiemetics; Lansky performance scale of above 50 (for patients aged 10 years or less) or Eastern Cooperative Oncology Group performance scale less than 3 and normal electrocardiogram (ECG) before the initiation of the prophylactic antiemetics.

Критерии исключения

• Children with history of allergy to olanzapine or metoclopramide; patient with renal failure, congestive heart failure, or any uncontrolled disease except for malignancy; serum creatinine more than upper limit of normal (ULN) for age; serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) four times the ULN for age and serum bilirubin 1.5 times ULN for age; patient with history of central nervous system disease including brain metastasis, seizure disorder, or psychosis; patients on treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, or phenothiazine.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Children's Medical Center — Шанхай

Публикации

• 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. PMID 32568452
• 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. PMID 34400961
• 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. PMID 37539996
• 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. PMID 28325253
• 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. PMID 26768437
• 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. PMID 32931400
• 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. PMID 30246876

Идентификаторы

NCT: NCT07035821 · scmc

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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