Breakthrough Chemotherapy-Induced Vomiting (CIV) in Pediatric PatientsPhase 3NCT07035821
Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy
A Phase 3 study testing Olanzapine Tablets in people with Breakthrough Chemotherapy-Induced Vomiting (CIV) in Pediatric Patients and Pediatric Cancer, run by Shanghai Children's Medical Center at 1 site in China.
Trial summary
Breakthrough chemotherapy-induced vomiting (CIV) is defined as CIV occurring after adequate antiemetic prophylaxis. Olanzapine is recommended for the treatment of breakthrough CIV in children, without adequate evidence. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Breakthrough Chemotherapy-Induced Vomiting (CIV) in Pediatric Patients, Pediatric Cancer
- What is being tested?
- Olanzapine Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 30 Jul 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The major inclusion criteria were children aged 5 to 18 years at the time of study entry with documented cancer; receiving NK-1 inhibitor (aprepitant/fosaprepitant) and 5HT-3 antagonist (ondansetron) and/or dexamethasone as prophylactic antiemetics for CINV due to MEC or HEC; minimum body weight of 10 kg; development of breakthrough vomiting after starting prophylactic antiemetics; Lansky performance scale of above 50 (for patients aged 10 years or less) or Eastern Cooperative Oncology Group performance scale less than 3 and normal electrocardiogram (ECG) before the initiation of the prophylactic antiemetics.
Who cannot join
- Children with history of allergy to olanzapine or metoclopramide; patient with renal failure, congestive heart failure, or any uncontrolled disease except for malignancy; serum creatinine more than upper limit of normal (ULN) for age; serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) four times the ULN for age and serum bilirubin 1.5 times ULN for age; patient with history of central nervous system disease including brain metastasis, seizure disorder, or psychosis; patients on treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, or phenothiazine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Olanzapine for the Treatment of Breakthrough Chemotherapy-Induced Vomiting in Children: An Open-label, Randomized Phase 3 Trial
Breakthrough chemotherapy-induced vomiting (CIV) is defined as CIV occurring after adequate antiemetic prophylaxis. Olanzapine is recommended for the treatment of breakthrough CIV in children, without adequate evidence. We conducted an open-label, single-center, phase 3 randomized controlled trial comparing the safety and efficacy of olanzapine and metoclopramide for treating breakthrough CIV.
Read the detailed description
Children aged 5-18 years who developed breakthrough CIV after receiving highly emetogenic chemotherapy were randomly assigned to the control(placebo) or olanzapine arm. The primary objective of the study was to compare the complete response (CR) rates between patients receiving olanzapine or placebo for treating breakthrough CIV during 72 hours after the administration of the study drug. Secondary objectives were to compare CR rates for nausea and toxicities between the two arms.
- Being tested
- Olanzapine Tablets, Placebo
- Keywords
- chemotherapy, olanzapine, pediatric cancer, vomiting
- Medical subject headings
- Neoplasms, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olanzapine TabletsDrug
Oral olanzapine tablets
PlaceboDrug
Oral placebo
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine group | Experimental | Oral olanzapine tablets Receives: Drug: Olanzapine Tablets |
| Control group | Placebo comparator | Oral placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the CR rate for vomiting in the first 72 hours
The primary endpoint was the CR rate for vomiting in the first 72 hours of the initiation of olanzapine .
Measured: in the first 72 hours of the initiation of olanzapine
Secondary outcomes (1)
the CR rate for nausea in the first 72 hours of the initiation of olanzapine
The secondary endpoint was the CR rate for nausea in the first 72 hours of the initiation of olanzapine
Measured: in the first 72 hours of the initiation of olanzapine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breakthrough Chemotherapy-Induced Vomiting (CIV) in Pediatric PatientsStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The control group gave patients oral placebo, while the experimental group gave patients oral olanzapine
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035821
- Sponsor's protocol ID
- scmc
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Radhakrishnan V, Pai V, Rajaraman S, Mehra N, Ganesan T, Dhanushkodi M, Perumal Kalaiyarasi J, Rajan AK, Selvarajan G, Ranganathan R, Karunakaran P, Sagar TG. Olanzapine versus metoclopramide for the treatment of breakthrough chemotherapy-induced vomiting in children: An open-label, randomized phase 3 trial. Pediatr Blood Cancer. 2020 Sep;67(9):e28532. doi: 10.1002/pbc.28532. Epub 2020 Jun 22.
PubMed 32568452Moshayedi M, Salehifar E, Karami H, Hendouei N, Mousazadeh M, Alizadeh Haji S. Efficacy and Safety of Adding Olanzapine to the Standard Preventive Regimen for Chemotherapy-induced Nausea and Vomiting in Children: A Randomized Double-blind Controlled Trial. Iran J Pharm Res. 2021 Winter;20(1):318-326. doi: 10.22037/ijpr.2019.112514.13803.
PubMed 34400961Meena JP, Gupta AK, Jat KR, Anandani G, Sasidharan A, Tanwar P. Efficacy and Safety of Olanzapine for the Prevention of Chemotherapy-induced Nausea and Vomiting in Children: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Pediatr Hematol Oncol. 2023 Oct 1;45(7):361-369. doi: 10.1097/MPH.0000000000002737. Epub 2023 Aug 3.
PubMed 37539996Yoodee J, Permsuwan U, Nimworapan M. Efficacy and safety of olanzapine for the prevention of chemotherapy-induced nausea and vomiting: A systematic review and meta-analysis. Crit Rev Oncol Hematol. 2017 Apr;112:113-125. doi: 10.1016/j.critrevonc.2017.02.017. Epub 2017 Feb 20.
PubMed 28325253Chiu L, Chow R, Popovic M, Navari RM, Shumway NM, Chiu N, Lam H, Milakovic M, Pasetka M, Vuong S, Chow E, DeAngelis C. Efficacy of olanzapine for the prophylaxis and rescue of chemotherapy-induced nausea and vomiting (CINV): a systematic review and meta-analysis. Support Care Cancer. 2016 May;24(5):2381-2392. doi: 10.1007/s00520-016-3075-8. Epub 2016 Jan 15.
PubMed 26768437Naik RD, V S, Singh V, Pillai AS, Dhawan D, Bakhshi S. Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy: Investigator-Initiated, Randomized, Open-Label Trial. J Clin Oncol. 2020 Nov 10;38(32):3785-3793. doi: 10.1200/JCO.20.00871. Epub 2020 Sep 15.
PubMed 32931400Sutherland A, Naessens K, Plugge E, Ware L, Head K, Burton MJ, Wee B. Olanzapine for the prevention and treatment of cancer-related nausea and vomiting in adults. Cochrane Database Syst Rev. 2018 Sep 21;9(9):CD012555. doi: 10.1002/14651858.CD012555.pub2.
PubMed 30246876
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olanzapine for the Treatment of Breakthrough Chemotherapy-Induced Vomiting in Children: An Open-label, Randomized Phase 3 Trial
- ClinicalTrials.gov ID
- NCT07035821
- Acronym / sponsor ID
- scmc
- Keywords
- chemotherapy, olanzapine, pediatric cancer, vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 25 Jun 2025 (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.
Breakthrough chemotherapy-induced vomiting (CIV) is defined as CIV occurring after adequate antiemetic prophylaxis. Olanzapine is recommended for the treatment of breakthrough CIV in children, without adequate evidence. We conducted an open-label, single-center, phase 3 randomized controlled trial comparing the safety and efficacy of olanzapine and metoclopramide for treating breakthrough CIV.
Detailed description
Children aged 5-18 years who developed breakthrough CIV after receiving highly emetogenic chemotherapy were randomly assigned to the control(placebo) or olanzapine arm. The primary objective of the study was to compare the complete response (CR) rates between patients receiving olanzapine or placebo for treating breakthrough CIV during 72 hours after the administration of the study drug. Secondary objectives were to compare CR rates for nausea and toxicities between the two arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The control group gave patients oral placebo, while the experimental group gave patients oral olanzapine
| Arm | Type | Receives |
|---|---|---|
| Olanzapine group | Experimental | Drug: Olanzapine TabletsOral olanzapine tablets |
| Control group | Placebo comparator | Drug: PlaceboOral placebo |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The major inclusion criteria were children aged 5 to 18 years at the time of study entry with documented cancer; receiving NK-1 inhibitor (aprepitant/fosaprepitant) and 5HT-3 antagonist (ondansetron) and/or dexamethasone as prophylactic antiemetics for CINV due to MEC or HEC; minimum body weight of 10 kg; development of breakthrough vomiting after starting prophylactic antiemetics; Lansky performance scale of above 50 (for patients aged 10 years or less) or Eastern Cooperative Oncology Group performance scale less than 3 and normal electrocardiogram (ECG) before the initiation of the prophylactic antiemetics.
Key exclusion criteria (1 listed)
- Children with history of allergy to olanzapine or metoclopramide; patient with renal failure, congestive heart failure, or any uncontrolled disease except for malignancy; serum creatinine more than upper limit of normal (ULN) for age; serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) four times the ULN for age and serum bilirubin 1.5 times ULN for age; patient with history of central nervous system disease including brain metastasis, seizure disorder, or psychosis; patients on treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, or phenothiazine.
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 |
|---|---|---|
| Olanzapine TabletsOral olanzapine tablets | Drug | Olanzapine group |
| PlaceboOral placebo | Drug | Control group |
Primary outcome
the CR rate for vomiting in the first 72 hours
Time frame: in the first 72 hours of the initiation of olanzapine
The primary endpoint was the CR rate for vomiting in the first 72 hours of the initiation of olanzapine .
1 secondary outcome
the CR rate for nausea in the first 72 hours of the initiation of olanzapine
Time frame: in the first 72 hours of the initiation of olanzapine
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Results publication: PubMed 32568452Radhakrishnan V, Pai V, Rajaraman S, Mehra N, Ganesan T, Dhanushkodi M, Perumal Kalaiyarasi J, Rajan AK, Selvarajan G, Ranganathan R, Karunakaran P, Sagar TG. Olanzapine versus metoclopramide for the treatment of breakthrough chemotherapy-induced vomiting in children: An open-label, randomized phase 3 trial. Pediatr Blood Cancer. 2020 Sep;67(9):e28532. doi: 10.1002/pbc.28532. Epub 2020 Jun 22.
- Results publication: PubMed 34400961Moshayedi M, Salehifar E, Karami H, Hendouei N, Mousazadeh M, Alizadeh Haji S. Efficacy and Safety of Adding Olanzapine to the Standard Preventive Regimen for Chemotherapy-induced Nausea and Vomiting in Children: A Randomized Double-blind Controlled Trial. Iran J Pharm Res. 2021 Winter;20(1):318-326. doi: 10.22037/ijpr.2019.112514.13803.
- Results publication: PubMed 37539996Meena JP, Gupta AK, Jat KR, Anandani G, Sasidharan A, Tanwar P. Efficacy and Safety of Olanzapine for the Prevention of Chemotherapy-induced Nausea and Vomiting in Children: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Pediatr Hematol Oncol. 2023 Oct 1;45(7):361-369. doi: 10.1097/MPH.0000000000002737. Epub 2023 Aug 3.
- Results publication: PubMed 28325253Yoodee J, Permsuwan U, Nimworapan M. Efficacy and safety of olanzapine for the prevention of chemotherapy-induced nausea and vomiting: A systematic review and meta-analysis. Crit Rev Oncol Hematol. 2017 Apr;112:113-125. doi: 10.1016/j.critrevonc.2017.02.017. Epub 2017 Feb 20.
- Results publication: PubMed 26768437Chiu L, Chow R, Popovic M, Navari RM, Shumway NM, Chiu N, Lam H, Milakovic M, Pasetka M, Vuong S, Chow E, DeAngelis C. Efficacy of olanzapine for the prophylaxis and rescue of chemotherapy-induced nausea and vomiting (CINV): a systematic review and meta-analysis. Support Care Cancer. 2016 May;24(5):2381-2392. doi: 10.1007/s00520-016-3075-8. Epub 2016 Jan 15.
- Results publication: PubMed 32931400Naik RD, V S, Singh V, Pillai AS, Dhawan D, Bakhshi S. Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy: Investigator-Initiated, Randomized, Open-Label Trial. J Clin Oncol. 2020 Nov 10;38(32):3785-3793. doi: 10.1200/JCO.20.00871. Epub 2020 Sep 15.
- Results publication: PubMed 30246876Sutherland A, Naessens K, Plugge E, Ware L, Head K, Burton MJ, Wee B. Olanzapine for the prevention and treatment of cancer-related nausea and vomiting in adults. Cochrane Database Syst Rev. 2018 Sep 21;9(9):CD012555. doi: 10.1002/14651858.CD012555.pub2.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olanzapine Tablets in people with Breakthrough Chemotherapy-Induced Vomiting (CIV) in Pediatric Patients and Pediatric Cancer, run by Shanghai Children's Medical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: opening soon, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liting Yu (13636303912, yuliting20091396@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the CR rate for vomiting in the first 72 hours (time frame: in the first 72 hours of the initiation of olanzapine). 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 NCT07035821, which also lists 7 linked publications.
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 Jun 2025.