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

Part of paid clinical trials in San Francisco, California.

Sponsor
The Hospital for Sick Children
Study ID
NCT03118986
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
30 Months - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Olanzapine — DRUG
    olanzapine 0.1 mg/kg/dose (maximum 10 mg/dose) by mouth as a single daily dose based on actual body weight
  • Placebo Oral Tablet — DRUG
    Placebo tablets that look like olanzapine and will be dosed as if they are olanzapine

Study Details

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

Key Dates

Start date
Aug 10, 2017
Status verified
May 2025
Primary completion
Mar 31, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Olanzapine
    Standard antiemetics plus olanzapine
  • Placebo Comparator: Placebo Oral Tablet
    Standard antiemetics plus placebo

Primary Outcome Measure

Rate of CIV control during the acute phase [ Time Frame: up to 8 days ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of CaliforniaSan FranciscoCalifornia94158
The Children's Mercy HospitalKansas CityMissouri64108
Judy Vun
(816) 302-6797
Columbia University/Morgan Stanley Children's HospitalNew YorkNew York10032-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-7220
Juanita Cuffee
[email protected]
(919) 966-0017
Nationwide Children's HospitalColumbusOhio43205
Medical University of South CarolinaCharlestonSouth Carolina29425
Shanta Salzer
843-792-1463

Find similar trials in San Francisco, CA

By research site
University of California· San Francisco, CAThe Children's Mercy Hospital· Kansas City, MOColumbia University/Morgan Stanley Children's Hospital· New York, NYUniversity of North Carolina at Chapel Hill· Chapel Hill, NCNationwide Children's Hospital· Columbus, OHMedical University of South Carolina· Charleston, SC

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