Vomiting in Infants and/or ChildrenPhase 2NCT03118986
RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy
A Phase 2 study testing Olanzapine in people with Vomiting in Infants and/or Children and Nausea, run by The Hospital for Sick Children at 9 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 months to 18 years
- Conditions the study is for
- Vomiting in Infants and/or Children, Nausea, Hematopoietic System--Cancer
- What is being tested?
- Olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 10 Aug 2017to 12 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Planned receipt of HEC or cyclophosphamide ≥ 1 g/m2/day (≥ 33 mg/kg/day) for cancer treatment or autologous or allogeneic HSCT conditioning.81,82 Examples of HEC are: busulfan IV (myeloablative dosing), carboplatin ≥175mg/m²/dose, cisplatin ≥12mg/m²/dose, cytarabine ≥3g/m²/day, melphalan >140mg/m², methotrexate ≥12g/m²/dose and thiotepa ≥300mg/m²/dose.
Plan for inpatient admission from administration of first study drug dose until 24 hours following administration of last study drug dose.
Body weight of at least 12.5 kg
2.5 to < 18 years of age. Note that the minimum age requirement corresponds to an approximate body weight of 12.5 kg.
Samples for all laboratory tests will be obtained within one week prior to administration of the first chemotherapy dose of the study chemotherapy block or the first HSCT conditioning dose:
- Plasma creatinine within 1.5 times the upper limit of normal for age.
- Amylase within age-appropriate limits
- Plasma conjugated bilirubin within ≤ 3x upper limit of normal for age unless attributable to Gilbert's Syndrome
- ALT ≤ 5x upper limit of normal for age
Baseline ECG within the month prior to study drug administration without known clinically significant abnormalities including pathologic prolongation of QTc
A plan for scheduled, round-the-clock receipt of ondansetron, granisetron or palonosetron for antiemetic prophylaxis during administration of chemotherapy or HSCT conditioning.
Negative pregnancy test if female of childbearing potential
Patients of childbearing potential must consent to use adequate contraception (males and females) or agree to practice abstinence
Parent or child able to speak a language in which the (modified Pediatric Adverse Event Rating Scale (PAERS) is available.
Optional: Child participants in the optional assessment of nausea severity must be 4 to 18 years of age. Child and a parent/guardian must be English, Spanish or French-speaking. The Pediatric Nausea Assessment Tool58 (PeNAT) is validated in English-speaking children 4 to 18 years old with an English-speaking parent/guardian and has been translated into Spanish and French. The MAT is available in English, Spanish and French.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States5 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7220
Medical University of South Carolina
Charleston, South Carolina, 29425
Nationwide Children's Hospital
Columbus, Ohio, 43205
The Children's Mercy Hospital
Kansas City, Missouri, 64108
University of California
San Francisco, California, 94158
Canada3 sites
Centre Hospitalier Universitaire Sainte-Justine,
Montreal, Quebec, H3T 1C5
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9
India1 site
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: Randomized Controlled Trial of Olanzapine for the Control of Chemotherapy-induced Vomiting 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, 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
- Being tested
- Olanzapine, Placebo Oral Tablet
- Keywords
- olanzapine, vomiting, children, adolescents, bone marrow transplant, supportive care
- Medical subject headings
- Nausea, Neoplasms, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
olanzapine 0.1 mg/kg/dose (maximum 10 mg/dose) by mouth as a single daily dose based on actual body weight
Placebo Oral TabletDrug
Placebo tablets that look like olanzapine and will be dosed as if they are olanzapine
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Active comparator | Standard antiemetics plus olanzapine Receives: Drug: Olanzapine |
| Placebo Oral Tablet | Placebo comparator | Standard antiemetics plus placebo Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of chemotherapy-induced vomiting (CIV) control (complete plus partial control)
Complete CIV control is no vomiting/retching and no use of breakthrough antiemetic agents during the phase. Partial CIV is defined as no more than 2 vomits or retches during any 24-hour period.
Measured: up to 8 days
Rate of CIV control during the acute phase
Partial control is defined as no more than two vomits or retches during any 24-hr period
Measured: up to 8 days
Secondary outcomes (12)
complete and partial CINV control
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
Measured: up to 1 month
Safety profile of olanzapine based on toxicities
Based on descriptive statistics on reported toxicities.
Measured: up to 1 month
Safety profile of olanzapine based on weight
Based on descriptive statistics on reported body weight
Measured: up to 1 month
Safety profile of olanzapine based on Pediatric Adverse Event Rating Scale (PAERs)
Based on descriptive statistics on reported PAERs, will describe the most reported and most bothersome adverse events reported in the PAERs questionnaire.
Measured: up to 1 month
Safety profile of olanzapine based on prolactin
Based on descriptive statistics on reported prolactin, will report incidence of abnormal prolactin values comparing the two arms
Measured: up to 1 month
Safety profile of olanzapine based on amylase
Based on descriptive statistics on reported amylase, will report incidence of abnormal amylase values comparing the two arms
Measured: up to 1 month
Safety profile of olanzapine based on creatine phophotase
Based on descriptive statistics on reported creatine phophotase, will report incidence of abnormal creatine phophotase values comparing the two arms
Measured: up to 1 month
Safety profile of olanzapine based on triglycerides
Based on descriptive statistics on reported triglycerides, will report incidence of abnormal triglyceride values comparing the two arms
Measured: up to 1 month
Impact of olanzapine on HSCT outcomes on incidence of veno-occlusive disease
Looking at incidence of veno-occlusive disease
Measured: From first HSCT conditioning dose until 100 days post-HSCT
Impact of olanzapine on HSCT outcomes on incidence of GVHD
Looking at incidence of GVHD between the two arms
Measured: From first HSCT conditioning dose until 100 days post-HSCT
Impact of olanzapine on HSCT outcomes on severity of GVHD
Comparing the incidence of the different maximal grades of GVHD between the two arms
Measured: From first HSCT conditioning dose until 100 days post-HSCT
Association between PeNAT and MASCC Antiemesis Tool (MAT) scores
taking maximum daily PeNAT scale score and maximum nausea experience in MAT will estimate the degree of association between PeNAT and MAT
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start10 Aug 2017
- Primary completion23 Mar 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vomiting in Infants and/or ChildrenStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Children's Mercy Hospital Kansas City, St. Justine's Hospital, Columbia University, Medical University of South Carolina, CancerCare Manitoba, University of North Carolina, Chapel Hill, Nationwide Children's Hospital, All India Institute of Medical Sciences
- Responsible party
- Principal investigator, Lee Dupuis, The Hospital for Sick Children
- Investigators
- Lee Dupuis, RPh, PhD, Principal investigator, The Hospital for Sick ChildrenMuhammad Ali, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118986
- Sponsor's protocol ID
- 1000053716
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2017
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dupuis LL, Taddio A, Kerr EN, Kelly A, MacKeigan L. Development and validation of the pediatric nausea assessment tool for use in children receiving antineoplastic agents. Pharmacotherapy. 2006 Sep;26(9):1221-31. doi: 10.1592/phco.26.9.1221.
PubMed 16945043
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Olanzapine for the Control of Chemotherapy-induced Vomiting in Children Receiving Highly Emetogenic Chemotherapy
- ClinicalTrials.gov ID
- NCT03118986
- Acronym / sponsor ID
- 1000053716
- Keywords
- olanzapine, vomiting, children, adolescents, bone marrow transplant, supportive care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Children's Mercy Hospital Kansas City, St. Justine's Hospital, Columbia University, Medical University of South Carolina, CancerCare Manitoba, University of North Carolina, Chapel Hill, Nationwide Children's Hospital, All India Institute of Medical Sciences
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 23 Mar 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | Active comparator | Drug: OlanzapineStandard antiemetics plus olanzapine |
| Placebo Oral Tablet | Placebo comparator | Drug: Placebo Oral TabletStandard antiemetics plus placebo |
Who may qualify
- Ages
- 30 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olanzapineolanzapine 0.1 mg/kg/dose (maximum 10 mg/dose) by mouth as a single daily dose based on actual body weight | Drug | Olanzapine |
| Placebo Oral TabletPlacebo tablets that look like olanzapine and will be dosed as if they are olanzapine | Drug | Placebo Oral Tablet |
Primary outcome
Rate of chemotherapy-induced vomiting (CIV) control (complete plus partial control)
Time frame: up to 8 days
Complete CIV control is no vomiting/retching and no use of breakthrough antiemetic agents during the phase. Partial CIV is defined as no more than 2 vomits or retches during any 24-hour period.
Rate of CIV control during the acute phase
Time frame: up to 8 days
Partial control is defined as no more than two vomits or retches during any 24-hr period
12 secondary outcomes
complete and partial CINV control
Time frame: up to 1 month
Safety profile of olanzapine based on toxicities
Time frame: up to 1 month
Safety profile of olanzapine based on weight
Time frame: up to 1 month
Safety profile of olanzapine based on Pediatric Adverse Event Rating Scale (PAERs)
Time frame: up to 1 month
Safety profile of olanzapine based on prolactin
Time frame: up to 1 month
Safety profile of olanzapine based on amylase
Time frame: up to 1 month
Safety profile of olanzapine based on creatine phophotase
Time frame: up to 1 month
Safety profile of olanzapine based on triglycerides
Time frame: up to 1 month
Impact of olanzapine on HSCT outcomes on incidence of veno-occlusive disease
Time frame: From first HSCT conditioning dose until 100 days post-HSCT
Impact of olanzapine on HSCT outcomes on incidence of GVHD
Time frame: From first HSCT conditioning dose until 100 days post-HSCT
Impact of olanzapine on HSCT outcomes on severity of GVHD
Time frame: From first HSCT conditioning dose until 100 days post-HSCT
Association between PeNAT and MASCC Antiemesis Tool (MAT) scores
Time frame: up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 16945043Dupuis LL, Taddio A, Kerr EN, Kelly A, MacKeigan L. Development and validation of the pediatric nausea assessment tool for use in children receiving antineoplastic agents. Pharmacotherapy. 2006 Sep;26(9):1221-31. doi: 10.1592/phco.26.9.1221.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Dupuis, RPh, PhD principal investigator
The Hospital for Sick Children
Muhammad Ali, MD principal investigator
The Hospital for Sick Children
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olanzapine in people with Vomiting in Infants and/or Children and Nausea, run by The Hospital for Sick Children at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of chemotherapy-induced vomiting (CIV) control (complete plus partial control) (time frame: up to 8 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03118986, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.