RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy

Summary

Chemotherapy-induced nausea and vomiting (CINV) are among the most bothersome symptoms during cancer treatment according to children and their parents. Most children receiving highly emetogenic chemotherapy (HEC), including those receiving hematopoietic stem cell transplant (HSCT) conditioning, experience CIV despite receiving antiemetic prophylaxis. Olanzapine improves CINV control in adult cancer patients, has a track record of safe use in children with psychiatric illness, does not interact with chemotherapy and is inexpensive. We hypothesize that the addition of olanzapine to standard antiemetics will improve chemotherapy-induced vomiting (CIV) control in children receiving highly emetogenic chemotherapy

Conditions

• Vomiting in Infants and/or Children
• Nausea
• Hematopoietic System--Cancer
• Oncology

Interventions

DRUG

Olanzapine

olanzapine 0.1 mg/kg/dose (maximum 10 mg/dose) by mouth as a single daily dose based on actual body weight

DRUG

Placebo Oral Tablet

Placebo tablets that look like olanzapine and will be dosed as if they are olanzapine

Sponsors & Collaborators

• University of California, San Francisco

  collaborator OTHER

• Children's Mercy Hospital Kansas City

  collaborator OTHER

• St. Justine's Hospital

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• CancerCare Manitoba

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• The Hospital for Sick Children

  lead OTHER

Principal Investigators

• Lee Dupuis, RPh, PhD · The Hospital for Sick Children

• Muhammad Ali, MD · The Hospital for Sick Children

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

30 Months

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-10

Primary Completion

2026-03-31

Completion

2026-04-30

FDA Drug

Yes

Countries

• United States
• Canada
• India

Study Locations