Actively Recruiting

Phase 2
Age: 30Months - 18Years
All Genders
NCT03118986

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

Led by The Hospital for Sick Children · Updated on 2025-10-08

200

Participants Needed

10

Research Sites

450 weeks

Total Duration

On this page

Sponsors

T

The Hospital for Sick Children

Lead Sponsor

U

University of California, San Francisco

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 30Months - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Planned receipt of highly emetogenic chemotherapy (HEC) or cyclophosphamide 61 g/m2/day (633 mg/kg/day) for cancer treatment or autologous or allogeneic HSCT conditioning
  • Plan for inpatient admission from first study drug dose until 24 hours following last study drug dose
  • Body weight of at least 12.5 kg
  • Age between 2.5 months and under 18 years
  • Laboratory tests within one week prior to first chemotherapy or HSCT dose showing: plasma creatinine within 1.5 times the upper limit of normal for age, amylase within age-appropriate limits, plasma conjugated bilirubin 3 3x upper limit of normal for age unless Gilbert's Syndrome, ALT 4 5x upper limit of normal for age
  • Baseline ECG within one month prior to study drug administration without clinically significant abnormalities including no pathologic QTc prolongation
  • Scheduled, round-the-clock use of ondansetron, granisetron, or palonosetron for antiemetic prophylaxis during chemotherapy or HSCT conditioning
  • Negative pregnancy test if female of childbearing potential
  • Agreement to use adequate contraception or abstinence if of childbearing potential
  • Parent or child able to speak a language in which the modified Pediatric Adverse Event Rating Scale (PAERS) is available
  • For optional nausea severity assessment, children must be 4 to 18 years old with English, Spanish, or French speaking parent or guardian
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 10 locations

1

University of California

San Francisco, California, United States, 94158

Actively Recruiting

2

The Children's Mercy Hospital

Kansas City, Missouri, United States, 64108

Actively Recruiting

3

Columbia University/Morgan Stanley Children's Hospital

New York, New York, United States, 10032

Withdrawn

4

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599-7220

Actively Recruiting

5

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Actively Recruiting

6

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

7

Cancer Care Manitoba

Winnipeg, Manitoba, Canada, R3E 0V9

Actively Recruiting

8

Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1X8

Actively Recruiting

9

Centre Hospitalier Universitaire Sainte-Justine,

Montreal, Quebec, Canada, H3T 1C5

Terminated

10

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India, 110029

Actively Recruiting

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Research Team

L

Lee Dupuis, RPh, PhD

CONTACT

M

Muhammad Ali, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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