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Lower dose of olanzapine may ease chemo nausea with less drowsiness

NCT ID NCT07403370

Symptom relief Sponsor: Shandong Cancer Hospital and Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study looked at 2,000 adults with solid tumors to find the best dose of olanzapine for preventing nausea and vomiting caused by strong chemotherapy. Researchers compared 2.5 mg, 5 mg, and 10 mg doses to see which works best with the fewest side effects like daytime sleepiness. The goal is to improve comfort during cancer treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

2,493 people

The number who actually took part.

Started

Jan 2026

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Olanzapine was used to prevent nausea and vomiting (HER-INV) in solid tumors patients receiving highly emetogenic regimens. 2. Randomized controlled trials (RCTs), including conference abstracts if sufficient data are provided. 3. 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. Exclusion Criteria: 1. Non-solid tumors patients, non-randomized studies, observational studies, case reports, reviews. 2. Studies involving pediatric populations, non-HEC regimens. 3. Studies where olanzapine is used as rescue medication only. Studies with overlapping patient populations (the most recent or complete publication will be selected).

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Conditions

The condition(s) this trial relates to.

Nausea neoplasm Vomiting

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nausea and vomiting Olanzapine Solid tumours

Contacts and locations

Locations

  • Department of Medical Oncology

    Jinan, Shandong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.