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NCT03118986 · ClinicalTrials.gov registry record · Phase 2
RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy
A Phase 2 study of Oncology and Nausea, sponsored by The Hospital for Sick Children.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 10
- Study locations
NCT03118986: Recruiting Phase 2 study of Oncology and Nausea, sponsored by The Hospital for Sick Children.
NCT03118986 is a Phase 2 study of Oncology and Nausea that is actively recruiting participants, run by The Hospital for Sick Children. The registered enrollment target is 200 participants, below the 519-participant average among 24 other Oncology trials with a reported enrollment target (61% lower). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03118986, a Phase 2 study of Oncology and Nausea, is actively recruiting participants, sponsored by The Hospital for Sick Children.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 10
- Study locations
Study 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
Primary Outcome
Complete CIV control is no vomiting/retching and no use of breakthrough antiemetic agents during phase
Conditions Studied
Interventions
- DRUG Olanzapine
- DRUG Placebo Oral Tablet
Study Locations (10)
California
- University of California - San Francisco
Missouri
- The Children's Mercy Hospital - Kansas City
New York
- Columbia University/Morgan Stanley Children's Hospital - New York
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Ohio
- Nationwide Children's Hospital - Columbus
South Carolina
- Medical University of South Carolina - Charleston
Manitoba
- Cancer Care Manitoba - Winnipeg
Ontario
- Hospital for Sick Children - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2017-08-10 |
| Est. Completion | 2026-04 |
| Phase | Phase 2 |
What NCT03118986 shows while recruiting
NCT03118986 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 519-participant average among 24 other Oncology trials with a reported enrollment target (61% lower).
The record links to 4 conditions, with Oncology appearing as the primary indexed condition, and to 2 interventions - of which Olanzapine is the first listed.
NCT03118986 lists 10 locations in 10 states (California, Missouri, New York).
Frequently Asked Questions
What is clinical trial NCT03118986 about?
NCT03118986 is a clinical study titled "RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy". 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, expe...
What is the current status of trial NCT03118986?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2017-08-10. Estimated completion is 2026-04.
What conditions does trial NCT03118986 study?
This clinical trial studies the following conditions: Oncology, Nausea, Hematopoietic System--Cancer, Vomiting in Infants and/or Children.
What interventions are being tested in trial NCT03118986?
The interventions under investigation include: Olanzapine (DRUG), Placebo Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT03118986?
This trial is sponsored by The Hospital for Sick Children, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03118986 being conducted?
This trial has 10 study locations across California, Missouri, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03118986's enrollment target sits among peer trials
200 10th of 24 higher than 15 of 24 other Oncology trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oncology trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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