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Can two common drugs beat chemo nausea? large trial seeks answers

NCT ID NCT03367572

Symptom relief Sponsor: University of Rochester NCORP Research Base 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase 3 trial tested whether adding prochlorperazine or olanzapine to standard anti-nausea medication (netupitant/palonosetron and dexamethasone) better controls nausea and vomiting caused by chemotherapy in breast cancer patients. Over 1,300 women receiving common chemo drugs like doxorubicin or cyclophosphamide took part. The study compared nausea ratings on a 7-point scale across two chemotherapy cycles to see if the extra drugs made a meaningful difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Prochlorperazine or olanzapine added to netupitant/palonosetron hydrochloride and dexamethasone
What this could lead to
If successful, adding prochlorperazine or olanzapine could provide better relief from chemotherapy-induced nausea and vomiting for breast cancer patients.
What could go wrong
This is a completed phase 3 trial, so results are available but may show only modest improvement. Side effects of the additional drugs (e.g., drowsiness, dizziness) could outweigh benefits for some patients.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,363 people

The number who actually took part.

Started

Apr 2018

Finished

Apr 2024

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.

Ages

18 years and older

Sex

Female participants only

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: * Have a diagnosis of breast cancer and be chemotherapy naive; NOTE: prior methotrexate for non-cancerous conditions is allowed * Be scheduled to receive a single-day chemotherapy regimen that contains doxorubicin and/or cyclophosphamide and/or carboplatin. Single-day chemotherapy is defined as only one infusion or injection per cycle. Herceptin (trastuzumab) and other chemotherapy agents will be allowed with any of these regimens * Be scheduled to receive an antiemetic regimen that does not contain Akynzeo; in addition, the antiemetic regimen must conform with American Society of Clinical Oncology (ASCO) Clinical Practice Guidelines at cycle 1 * Be able to read English * Have the ability to give written informed consent * Have Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * NOTE: patients 80 years of age or older must have approval from an oncologist or their designee to participate in this study * NOTE: patients currently receiving warfarin must have approval from an oncologist or their designee to participate in this study * Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, or abstinence) for the duration of the study and have a negative pregnancy test within 10 days prior to the initiation of chemotherapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately * CYCLE II PORTION ONLY: Only participants with a nausea score \>= 3 at least once on the diary assessment from cycle 1 can be randomized for cycle 2 * CYCLE II PORTION ONLY: Participants must be scheduled to receive the same chemotherapy regimen as received at cycle 1 Exclusion Criteria: * Have clinical evidence of current or impending bowel obstruction * Have a known history of central nervous system disease (e.g., brain metastases or a seizure disorder) * Have dementia * Have uncontrolled diabetes mellitus or uncontrolled hyperglycemia * Have severe hepatic impairment, severe renal impairment, or end-stage renal disease as determined by the treating physician * Have had long term treatment (\> 5 days within the past 30 days) with an antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period; NOTE: participants could have received prochlorperazine and other phenothiazines as antiemetic therapy on a short term basis (i.e., =\< 5 days) * Have a known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 months * Be taking benzodiazepines regularly (\> 5 days within the past 30 days); pro re nata (PRN) use (=\< 5 days) for the short-term relief of the symptoms of anxiety, anxiety associated with depressive symptoms, or as a rescue medication for breakthrough CINV is allowed * Be taking anticholinergic medications * Be receiving quinolone antibiotic therapy * Be taking amifostine (Ethiofos) * Have a known hypersensitivity to olanzapine or to phenothiazines * CYCLE II PORTION ONLY: Must not have received Akynzeo at cycle 1 * CYCLE II PORTION ONLY: Must still meet all the exclusion criteria for cycle 1

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

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

Breast carcinoma

Contacts and locations

Locations

  • Aurora NCORP

    Milwaukee, Wisconsin, 53226, United States

  • Cancer Research Consortium of West Michigan

    Grand Rapids, Michigan, 49503, United States

  • Cancer Research for the Ozarks NCORP

    Springfield, Missouri, 65804, United States

  • Columbus NCORP

    Columbus, Ohio, 43215, United States

  • Dayton Clinical Oncology Program

    Dayton, Ohio, 45459, United States

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526, United States

  • Geisinger Cancer Institute NCORP

    Danville, Pennsylvania, 17822, United States

  • Greenville NCORP

    Greenville, South Carolina, 29615, United States

  • Gulf South MU-NCORP

    New Orleans, Louisiana, 70112, United States

  • Gundersen Health System

    La Crosse, Wisconsin, 54601, United States

  • Hawaii MU NCORP

    Honolulu, Hawaii, 96813, United States

  • Health Partners Inc

    Minneapolis, Minnesota, 55454, United States

  • Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106, United States

  • Nevada Cancer Research Foundation NCORP

    Las Vegas, Nevada, 89106, United States

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301, United States

  • Southeast Clinical Oncology Research Program

    Winston-Salem, North Carolina, 27104, United States

  • University of Rochester NCORP Research Base

    Rochester, New York, 14642, United States

  • Upstate Carolina NCORP

    Spartanburg, South Carolina, 29303, United States

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