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

NCT07035821 | Not Yet Recruiting Phase 3

• 1 other identifier: scmc
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breakthrough Chemotherapy-Induced Vomiting (CIV) in Pediatric Patients; Pediatric Cancer

Keywords

chemotherapy; olanzapine; pediatric cancer; vomiting

Outcome Measures

Primary Outcomes (1)

• the CR rate for vomiting in the first 72 hours

  The primary endpoint was the CR rate for vomiting in the first 72 hours of the initiation of olanzapine .

  in the first 72 hours of the initiation of olanzapine

Secondary Outcomes (1)

• the CR rate for nausea in the first 72 hours of the initiation of olanzapine

  in the first 72 hours of the initiation of olanzapine

Study Arms (2)

Olanzapine group

EXPERIMENTAL

Oral olanzapine tablets

Drug: Olanzapine Tablets

Control group

PLACEBO COMPARATOR

Oral placebo

Drug: Placebo

Interventions

Olanzapine Tablets DRUG

Oral olanzapine tablets

Olanzapine group

Placebo DRUG

Oral placebo

Control group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Children's Medical Center: lead

Study Sites (1)

Shanghai Children's Medical Center

Shanghai, China

Location

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Vomiting

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Liting Yu

CONTACT

13636303912; yuliting20091396@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients were randomized to one of the prespecified two arms (arm A: olanzapine or arm B: placebo) if they developed breakthrough vomiting. The department of biostatistics and cancer registry at the institute assisted in the random allocation of the patients. Randomization was performed by generating random number tables through customized computer program or the proposed total number of cases in the study, and the randomization codes were kept in sequentially numbered sealed envelopes. The envelopes were kept in the pediatric ward and opened when a patient was identified for randomization. A document was then prepared giving the allocation of all the subjects to the two arms in chronological order.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The control group gave patients oral placebo, while the experimental group gave patients oral olanzapine

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)