Chemotherapy Induced Nausea and VomitingPhase 3NCT06850454
Olanzapine Versus Placebo for Moderately Emetogenic Chemotherapy
A Phase 3 study testing olanzapine in people with Chemotherapy Induced Nausea and Vomiting, run by Mahidol University at 1 site in Thailand.
Trial summary
A study comparing efficacy of olanzapine versus placebo to prevent nausea and vomiting from moderate emetic risk chemotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy Induced Nausea and Vomiting
- 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
- 140 participants
- Where
- 1 siteThailand
- Study dates
- 10 Jan 2025to 31 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed cancer patients who will be started on first dose of oxaliplatin, irinotecan or carboplatin
- age of >18 years old
Who cannot join
- pregnancy or breast feeding
- has emetic episode within 24 hours
- gut obstruction
- uncontrolled brain metastasis
- allergy to or current use of olanzapine
- concomittant moderate or high emetogenic chemotherapy on day 2-5
- Total bilirubin > 2 mg/dl or creatinine clearance < 30 ml/min
- unable to swallow drug
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
Suthinee Ithimakin, MD, 66898127440, aesi105@yahoo.co.th
About this study
Official title: A Prospective Randomized, Double-blind Controlled Trial of Olanzapine Versus Placebo in Addition to Ondansetron Plus Dexamethasone As Antiemetic Prophylaxis in Patients Receiving Moderately Emetogenic Chemotherapy
A study comparing efficacy of olanzapine versus placebo to prevent nausea and vomiting from moderate emetic risk chemotherapy
Read the detailed description
A randomized study comparing olanzapine versus placebo in addition to standard antiemetic regimen for preventing nausea and vomiting from moderately emetogenic chemotherapy
- Conditions
- Chemotherapy Induced Nausea and Vomiting
- Being tested
- olanzapine, Placebo
- Keywords
- olanzapine, moderately emetogenic chemotherapy, carboplatin, irinotecan, oxaliplatin
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olanzapineDrug
olanzapine 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4
PlaceboDrug
placebo 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4
| Study group | Role | What they receive |
|---|---|---|
| olanzapine | Experimental | olanzapine 5 mg on day 1-4 Receives: Drug: olanzapine |
| placebo | Placebo comparator | placebo 5 mg day 1-4 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
total protection rate of nausea and vomiting
Proportion of patients without vomiting or requiring rescue therapy and VAS nausea score of less than 25 mm
Measured: 5 days
Secondary outcomes (6)
no nausea rate
Measured: 5 days
severity of nausea and vomiting
Number of patients with grade of nausea or vomiting according to CT-CAE
Measured: 5 days
adverse events
Number of patients with other adverse event(s)
Measured: 5 days
rescue therapy
Number of patients requiring additional therapy
Measured: 5 days
quality of life score
EQ-5D-5L score
Measured: 5 days
Cost
medical cost excluding chemotherapy and prophylactic measures
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start10 Jan 2025
- Primary completion10 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy Induced Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, suthinee ithimakin, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850454
- Sponsor's protocol ID
- 811/2567(IRB3)
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared upon request
Publications
Shen J, Zhao J, Jin G, Li H, Jiang Y, Wu Y, Gao J, Chen F, Li J, Wang W, Li Q. A prospective randomized controlled clinical trial investigating the efficacy of low-dose olanzapine in preventing nausea and vomiting associated with oxaliplatin-based and irinotecan-based chemotherapy. J Cancer Res Clin Oncol. 2024 May 28;150(5):283. doi: 10.1007/s00432-024-05712-7.
PubMed 38806870Yamamoto S, Iihara H, Uozumi R, Kawazoe H, Tanaka K, Fujita Y, Abe M, Imai H, Karayama M, Hayasaki Y, Hirose C, Suda T, Nakamura K, Suzuki A, Ohno Y, Morishige KI, Inui N. Efficacy and safety of 5 mg olanzapine for nausea and vomiting management in cancer patients receiving carboplatin: integrated study of three prospective multicenter phase II trials. BMC Cancer. 2021 Jul 19;21(1):832. doi: 10.1186/s12885-021-08572-3.
PubMed 34281514
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized, Double-blind Controlled Trial of Olanzapine Versus Placebo in Addition to Ondansetron Plus Dexamethasone As Antiemetic Prophylaxis in Patients Receiving Moderately Emetogenic Chemotherapy
- ClinicalTrials.gov ID
- NCT06850454
- Acronym / sponsor ID
- 811/2567(IRB3)
- Conditions
- Chemotherapy Induced Nausea and Vomiting
- Keywords
- olanzapine, moderately emetogenic chemotherapy, carboplatin, irinotecan, oxaliplatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 10 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 27 Feb 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.
A study comparing efficacy of olanzapine versus placebo to prevent nausea and vomiting from moderate emetic risk chemotherapy
Detailed description
A randomized study comparing olanzapine versus placebo in addition to standard antiemetic regimen for preventing nausea and vomiting from moderately emetogenic chemotherapy
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| olanzapine | Experimental | Drug: olanzapineolanzapine 5 mg on day 1-4 |
| placebo | Placebo comparator | Drug: Placeboplacebo 5 mg day 1-4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- histologically confirmed cancer patients who will be started on first dose of oxaliplatin, irinotecan or carboplatin
- age of >18 years old
Key exclusion criteria (8 listed)
- pregnancy or breast feeding
- has emetic episode within 24 hours
- gut obstruction
- uncontrolled brain metastasis
- allergy to or current use of olanzapine
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 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4 | Drug | olanzapine |
| Placeboplacebo 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4 | Drug | placebo |
Primary outcome
total protection rate of nausea and vomiting
Time frame: 5 days
Proportion of patients without vomiting or requiring rescue therapy and VAS nausea score of less than 25 mm
6 secondary outcomes
no nausea rate
Time frame: 5 days
severity of nausea and vomiting
Time frame: 5 days
adverse events
Time frame: 5 days
rescue therapy
Time frame: 5 days
quality of life score
Time frame: 5 days
Cost
Time frame: 5 days
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 27 Feb 2025.
- Background: PubMed 38806870Shen J, Zhao J, Jin G, Li H, Jiang Y, Wu Y, Gao J, Chen F, Li J, Wang W, Li Q. A prospective randomized controlled clinical trial investigating the efficacy of low-dose olanzapine in preventing nausea and vomiting associated with oxaliplatin-based and irinotecan-based chemotherapy. J Cancer Res Clin Oncol. 2024 May 28;150(5):283. doi: 10.1007/s00432-024-05712-7.
- Background: PubMed 34281514Yamamoto S, Iihara H, Uozumi R, Kawazoe H, Tanaka K, Fujita Y, Abe M, Imai H, Karayama M, Hayasaki Y, Hirose C, Suda T, Nakamura K, Suzuki A, Ohno Y, Morishige KI, Inui N. Efficacy and safety of 5 mg olanzapine for nausea and vomiting management in cancer patients receiving carboplatin: integrated study of three prospective multicenter phase II trials. BMC Cancer. 2021 Jul 19;21(1):832. doi: 10.1186/s12885-021-08572-3.
- Individual participant dataSharing planned: Yes. IPD will be shared upon request
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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.
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 in people with Chemotherapy Induced Nausea and Vomiting, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 Feb 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 Thailand. 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 Suthinee Ithimakin Ithimakin, MD (66898127440, aesi105@yahoo.co.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total protection rate of nausea and vomiting (time frame: 5 days). 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 NCT06850454, which also lists 2 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 27 Feb 2025.