Solid TumoursNCT07403370
Olanzapine Dose Comparison for the Prevention of HER-INV: A Network Meta-Analysis
An observational study of Solid Tumours and Olanzapine, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
Olanzapine is an effective antiemetic agent for preventing highly emetogenic regimens-induced nausea and vomiting (HER-INV) in patients receiving highly emetogenic regimens (HER). The optimal dose remains debated, with the standard 10 mg dose often causing significant daytime sedation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Tumours, Olanzapine, Nausea and Vomiting
- What is being tested?
- Olanzapine (dose comparison: 2.5 mg, 5 mg, 10 mg)
- How many people
- 2,493 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2026to 30 Mar 2026
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with solid tumors received different doses of olanzapine (2.5 mg, 5 mg, 10 mg) as an add-on to standard antiemetic prophylaxis for the prevention of HER-induced nausea and vomiting in adult (≥18 years) patients with solid tumors receiving highly emetogenic regimens.
Who may be able to join
- Olanzapine was used to prevent nausea and vomiting (HER-INV) in solid tumors patients receiving highly emetogenic regimens.
- Randomized controlled trials (RCTs), including conference abstracts if sufficient data are provided.
- Adult patients (≥18 years) with solid tumors receiving highly emetogenic chemotherapy (HEC).
- 3. Olanzapine at 2.5 mg, 5 mg, or 10 mg, added to a standard triple antiemetic regimen (NK1 receptor antagonist + 5-HT3 receptor antagonist + dexamethasone).
- 4. Any of the other three olanzapine doses or placebo (2.5 mg vs. 5 mg vs. 10 mg, or vs. placebo).
- 5. At least one of the pre-specified efficacy or safety outcomes must be reported.
Who cannot join
- Non-solid tumors patients, non-randomized studies, observational studies, case reports, reviews.
- Studies involving pediatric populations, non-HEC regimens.
- Studies where olanzapine is used as rescue medication only. Studies with overlapping patient populations (the most recent or complete publication will be selected).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Olanzapine 2.5 mg Versus 5 mg Versus 10 mg in Highly Emetogenic Regimens: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.
Olanzapine is an effective antiemetic agent for preventing highly emetogenic regimens-induced nausea and vomiting (HER-INV) in patients receiving highly emetogenic regimens (HER). The optimal dose remains debated, with the standard 10 mg dose often causing significant daytime sedation. Recent evidence suggests that lower doses (2.5 mg and 5 mg) may offer comparable efficacy with improved tolerability. However, no head-to-head randomized controlled trials (RCTs) directly compare all three doses.
Read the detailed description
To compare the relative efficacy and safety of olanzapine at 2.5 mg, 5 mg, and 10 mg, in combination with standard triple antiemetic prophylaxis, for the prevention of HER-INV in adult patients undergoing HER, using a network meta-analysis (NMA) of RCTs. RCTs comparing any two doses of olanzapine (2.5 mg, 5 mg, 10 mg) in adults with solid tumors.
Inclusion Criteria:
- Olanzapine was used to prevent nausea and vomiting (HER-INV) in solid tumors patients receiving highly emetogenic regimens
- Randomized controlled trials (RCTs), including conference abstracts if sufficient data are provided.
- Adult patients (≥18 years) with solid tumors receiving highly emetogenic chemotherapy (HEC).
- Olanzapine at 2.5 mg, 5 mg, or 10 mg, added to a standard triple antiemetic regimen (NK1 receptor antagonist + 5-HT3 receptor antagonist + dexamethasone).
- Any of the other three olanzapine doses or placebo (2.5 mg vs. 5 mg vs. 10 mg, or vs. placebo).
- At least one of the pre-specified efficacy or safety outcomes must be reported.
Exclusion Criteria:
- Non-solid tumors patients, non-randomized studies, observational studies, case reports, reviews.
- Studies involving pediatric populations, non-HEC regimens.
- Studies where olanzapine is used as rescue medication only.
- Studies with overlapping patient populations (the most recent or complete publication will be selected).
Information Sources: Electronic databases: PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science Core Collection. We will also search clinical trial registries (ClinicalTrials.gov, WHO ICTRP) and manually review reference lists of relevant systematic reviews and included studies.
Risk of Bias Assessment: The risk of bias for individual RCTs will be assessed using the revised Cochrane Risk of Bias tool for randomized trials (RoB 2.0) by two independent reviewers.
Subgroup Analyses: Subgroup analyses are planned by treatment regimens (such as: cisplatin-based vs. AC-based et al.).
- Conditions
- Solid Tumours, Olanzapine, Nausea and Vomiting
- Being tested
- Olanzapine (dose comparison: 2.5 mg, 5 mg, 10 mg)
- Keywords
- Olanzapine, Network Meta-Analysis, High emetic risk, Nausea and Vomiting, Solid tumours
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olanzapine (dose comparison: 2.5 mg, 5 mg, 10 mg)Drug
Olanzapine (dose: 2.5 mg) vs. olanzapine (dose: 5 mg) vs. olanzapine (dose: 10 mg)
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine Doses 2.5mg | Not described Receives: Drug: Olanzapine (dose comparison: 2.5 mg, 5 mg, 10 mg) | |
| Olanzapine Doses 5mg | Not described Receives: Drug: Olanzapine (dose comparison: 2.5 mg, 5 mg, 10 mg) | |
| Olanzapine Doses 10mg | Not described Receives: Drug: Olanzapine (dose comparison: 2.5 mg, 5 mg, 10 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The complete response rate of nausea and vomiting in the overall phase (including acuted and delayed phase) by highly emetogenic regimens in solid tummors.
Nausea and vomiting complete response (CR; no vomiting or retching, no rescue medication) rate in the overall phase (including acuted [0-24h] and delayed [>24h] phase ) after highly emetogenic regimens in solid tummors .
Measured: Nausea and vomiting complete response was assesed during the treatment period (or during the overall assessment period) after the initiation of highly emetogenic regimens, up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start18 Jan 2026
- Primary completion15 Feb 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumoursStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 2,493 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fangchao Zheng, MD, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403370
- Sponsor's protocol ID
- SDTHEC-IF
- Status last verified
- Sep 2026
- First submitted
- 18 Jan 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olanzapine 2.5 mg Versus 5 mg Versus 10 mg in Highly Emetogenic Regimens: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.
- ClinicalTrials.gov ID
- NCT07403370
- Acronym / sponsor ID
- SDTHEC-IF
- Conditions
- Solid Tumours, Olanzapine, Nausea and Vomiting
- Keywords
- Olanzapine, Network Meta-Analysis, High emetic risk, Nausea and Vomiting, Solid tumours
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,493 participants (actual)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 18 Jan 2026 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 11 Feb 2026 (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.
Olanzapine is an effective antiemetic agent for preventing highly emetogenic regimens-induced nausea and vomiting (HER-INV) in patients receiving highly emetogenic regimens (HER). The optimal dose remains debated, with the standard 10 mg dose often causing significant daytime sedation. Recent evidence suggests that lower doses (2.5 mg and 5 mg) may offer comparable efficacy with improved tolerability. However, no head-to-head randomized controlled trials (RCTs) directly compare all three doses.
Detailed description
To compare the relative efficacy and safety of olanzapine at 2.5 mg, 5 mg, and 10 mg, in combination with standard triple antiemetic prophylaxis, for the prevention of HER-INV in adult patients undergoing HER, using a network meta-analysis (NMA) of RCTs. RCTs comparing any two doses of olanzapine (2.5 mg, 5 mg, 10 mg) in adults with solid tumors.
Inclusion Criteria:
- Olanzapine was used to prevent nausea and vomiting (HER-INV) in solid tumors patients receiving highly emetogenic regimens
- Randomized controlled trials (RCTs), including conference abstracts if sufficient data are provided.
- Adult patients (≥18 years) with solid tumors receiving highly emetogenic chemotherapy (HEC).
- Olanzapine at 2.5 mg, 5 mg, or 10 mg, added to a standard triple antiemetic regimen (NK1 receptor antagonist + 5-HT3 receptor antagonist + dexamethasone).
- Any of the other three olanzapine doses or placebo (2.5 mg vs. 5 mg vs. 10 mg, or vs. placebo).
- At least one of the pre-specified efficacy or safety outcomes must be reported.
Exclusion Criteria:
- Non-solid tumors patients, non-randomized studies, observational studies, case reports, reviews.
- Studies involving pediatric populations, non-HEC regimens.
- Studies where olanzapine is used as rescue medication only.
- Studies with overlapping patient populations (the most recent or complete publication will be selected).
Information Sources: Electronic databases: PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science Core Collection. We will also search clinical trial registries (ClinicalTrials.gov, WHO ICTRP) and manually review reference lists of relevant systematic reviews and included studies.
Risk of Bias Assessment: The risk of bias for individual RCTs will be assessed using the revised Cochrane Risk of Bias tool for randomized trials (RoB 2.0) by two independent reviewers.
Subgroup Analyses: Subgroup analyses are planned by treatment regimens (such as: cisplatin-based vs. AC-based et al.).
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Olanzapine Doses 2.5mg | – | Drug: Olanzapine (dose comparison: 2.5 mg, 5 mg, 10 mg) |
| Olanzapine Doses 5mg | – | Drug: Olanzapine (dose comparison: 2.5 mg, 5 mg, 10 mg) |
| Olanzapine Doses 10mg | – | Drug: Olanzapine (dose comparison: 2.5 mg, 5 mg, 10 mg) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with solid tumors received different doses of olanzapine (2.5 mg, 5 mg, 10 mg) as an add-on to standard antiemetic prophylaxis for the prevention of HER-induced nausea and vomiting in adult (≥18 years) patients with solid tumors receiving highly emetogenic regimens.
Key inclusion criteria (6 listed)
- Olanzapine was used to prevent nausea and vomiting (HER-INV) in solid tumors patients receiving highly emetogenic regimens.
- Randomized controlled trials (RCTs), including conference abstracts if sufficient data are provided.
- Adult patients (≥18 years) with solid tumors receiving highly emetogenic chemotherapy (HEC).
- 3. Olanzapine at 2.5 mg, 5 mg, or 10 mg, added to a standard triple antiemetic regimen (NK1 receptor antagonist + 5-HT3 receptor antagonist + dexamethasone).
- 4. Any of the other three olanzapine doses or placebo (2.5 mg vs. 5 mg vs. 10 mg, or vs. placebo).
Key exclusion criteria (3 listed)
- Non-solid tumors patients, non-randomized studies, observational studies, case reports, reviews.
- Studies involving pediatric populations, non-HEC regimens.
- Studies where olanzapine is used as rescue medication only. Studies with overlapping patient populations (the most recent or complete publication will be selected).
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 (dose comparison: 2.5 mg, 5 mg, 10 mg)Olanzapine (dose: 2.5 mg) vs. olanzapine (dose: 5 mg) vs. olanzapine (dose: 10 mg) | Drug | Olanzapine Doses 10mg, Olanzapine Doses 2.5mg, Olanzapine Doses 5mg |
Primary outcome
The complete response rate of nausea and vomiting in the overall phase (including acuted and delayed phase) by highly emetogenic regimens in solid tummors.
Time frame: Nausea and vomiting complete response was assesed during the treatment period (or during the overall assessment period) after the initiation of highly emetogenic regimens, up to 4 weeks.
Nausea and vomiting complete response (CR; no vomiting or retching, no rescue medication) rate in the overall phase (including acuted [0-24h] and delayed [>24h] phase ) after highly emetogenic regimens in solid tummors .
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 9 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumours and Olanzapine, run by Shandong Cancer Hospital and Institute 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 9 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The complete response rate of nausea and vomiting in the overall phase (including acuted and delayed phase) by highly emetogenic regimens in solid tummors. (time frame: Nausea and vomiting complete response was assesed during the treatment period (or during the overall assessment period) after the initiation of highly emetogenic regimens, up to 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.