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

Phase 2

Recruiting

• Conditions: Nausea; Oncology; Hematopoietic System--Cancer; Vomiting in Infants and/or Children
• Interventions: Drug: Placebo Oral Tablet; Drug: Olanzapine

• Registration Number: NCT03118986
• Lead Sponsor: The Hospital for Sick Children

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-16
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-18
• Study Start: 2017-08-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25
• Primary Completion: 2025-03
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Oral Tablet	Placebo Oral Tablet	Standard antiemetics plus placebo
Olanzapine	Olanzapine	Standard antiemetics plus olanzapine

Primary Outcome Measures

Name	Time	Method
Rate of CIV control during the acute phase	up to 8 days	Partial control is defined as no more than two vomits or retches during any 24-hr period

Secondary Outcome Measures

Name	Time	Method
Safety profile of olanzapine based on creatine phophotase	up to 1 month	Based on descriptive statistics on reported creatine phophotase, will report incidence of abnormal creatine phophotase values comparing the two arms
Safety profile of olanzapine based on amylase	up to 1 month	Based on descriptive statistics on reported amylase, will report incidence of abnormal amylase values comparing the two arms
complete and partial CINV control	up to 1 month	Complete CIV control is no vomiting/retching and no use of breakthrough antiemetic agents during phase, Partial control is defined as no more than two vomits or retches during any 24-hr period
Safety profile of olanzapine based on toxicities	up to 1 month	Based on descriptive statistics on reported toxicities.
Safety profile of olanzapine based on Pediatric Adverse Event Rating Scale (PAERs)	up to 1 month	Based on descriptive statistics on reported PAERs, will describe the most reported and most bothersome adverse events reported in the PAERs questionnaire.
Safety profile of olanzapine based on triglycerides	up to 1 month	Based on descriptive statistics on reported triglycerides, will report incidence of abnormal triglyceride values comparing the two arms
Impact of olanzapine on HSCT outcomes on incidence of veno-occlusive disease	From first HSCT conditioning dose until 100 days post-HSCT	Looking at incidence of veno-occlusive disease
Impact of olanzapine on HSCT outcomes on incidence of GVHD	From first HSCT conditioning dose until 100 days post-HSCT	Looking at incidence of GVHD between the two arms
Impact of olanzapine on HSCT outcomes on severity of GVHD	From first HSCT conditioning dose until 100 days post-HSCT	Comparing the incidence of the different maximal grades of GVHD between the two arms
Association between PeNAT and MASCC Antiemesis Tool (MAT) scores	up to 1 month	taking maximum daily PeNAT scale score and maximum nausea experience in MAT will estimate the degree of association between PeNAT and MAT
Safety profile of olanzapine based on weight	up to 1 month	Based on descriptive statistics on reported body weight
Safety profile of olanzapine based on prolactin	up to 1 month	Based on descriptive statistics on reported prolactin, will report incidence of abnormal prolactin values comparing the two arms

Trial Locations

Locations (10)

Cancer Care Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

Columbia University/Morgan Stanley Children's Hospital; 🇺🇸 New York, New York, United States

Centre Hospitalier Universitaire Sainte-Justine,; 🇨🇦 Montréal, Quebec, Canada

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

University of California; 🇺🇸 San Francisco, California, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

All India Institute of Medical Sciences; 🇮🇳 New Delhi, Delhi, India

The Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States