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

Sponsor
Shanghai Children's Medical Center
Study ID
NCT07035821
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
5 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Olanzapine Tablets — DRUG
    Oral olanzapine tablets
  • Placebo — DRUG
    Oral placebo

Study Details

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.

Key Dates

First listed
Jun 25, 2025
Start date
Jul 1, 2025
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Olanzapine group
    Oral olanzapine tablets
  • Placebo Comparator: Control group
    Oral placebo

Primary Outcome Measure

the CR rate for vomiting in the first 72 hours [ Time Frame: in the first 72 hours of the initiation of olanzapine ]

Central Contacts

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