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New tool predicts chemo sickness; drug shows promise

NCT ID NCT04817189

Symptom relief Sponsor: Helsinn Healthcare SA 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested if the drug Akynzeo can prevent nausea and vomiting in cancer patients getting moderate chemotherapy who are at high risk based on a special prediction tool. Over 400 adults took part. The goal was to see if Akynzeo works better than standard care over three rounds of chemo.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

414 people

The number who actually took part.

Started

Feb 2021

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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

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: * Adult patients aged ≥18 years * Patients with a risk score of ≥ 13 as calculated by the algorithm - see 3.6.3.1. Baseline/screening: VISIT 0 * Signed Informed consent * Both sexes * Patients with diagnosis of any cancer scheduled and intended to be treated for three consecutive cycles with a single dose of any IV MEC regimen, per cycle, including adjuvant or neo-adjuvant chemotherapy * Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * Use of Standard of Care defined as a 5-HT3 RA + Dexamethasone (or equivalent corticosteroid) based-regimen on day 1 of chemotherapy for CINV prevention * Naïve and non- naïve to chemotherapy * The enrolled women should be a) of non-childbearing potential or b) of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test done by health care team within 1-24 hours before dosing the antiemetic treatment in both arms and outcome recorded in the medical records * Able to comply with study requirements Exclusion Criteria: * Patients receiving highly emetogenic chemotherapy (including anthracycline+cyclophosphamide-based chemotherapy) * Patients receiving oral moderately emetogenic chemotherapy drugs * Patients receiving opioids within 2 weeks prior to trial enrollment (longer use allowed) * Use of olanzapine as prophylaxis of CINV * Patients scheduled to receive radiotherapy concurrently with chemotherapy * Any illness or condition that, in the opinion of the physician, may confound the results of the study or pose unwarranted risks in administering the investigational product to the patient. * Patients with mechanical risk factors for nausea (i.e. intestinal obstruction) * Patients with liver disease (as nausea is a common presenting symptom) * Patients with metabolic risk factors for nausea (i.e. electrolyte imbalances causing nausea/vomiting) * Chronic treatment with steroids (with the exception of inhaled or topical steroids) * Pregnancy and/or breast-feeding women * Women of childbearing potential refusing to use effective contraception during the whole study treatment and up to one month after study treatment with Akynzeo® * Use of Standard of Care including an NK-1 RA-based regimen to prevent CINV

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Conditions

The condition(s) this trial relates to.

cancer chemotherapy-induced toxicity Vomiting

As listed by the trial registrant

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

Chemotherapy induced nausea and vomiting

Contacts and locations

Locations

  • Complejo Hospitalario Universitario de A Coruña

    A Coruña, 15006, Spain

  • Evang. Kliniken Essen-Mitte

    Essen, Germany

  • Frauenklinik St. Louise

    Paderborn, Germany

  • General University Hospital in Prague

    Prague, Czechia

  • General University Hospital of Heraklion

    Heraklion, Greece

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 0802, Spain

  • Klinikum Ernst von Bergmann gemeinnützige GmbH

    Potsdam, Germany

  • München Klinik Neuperlach

    München, Germany

  • Shanghai Chest Hospital

    Shanghai, China

  • Shanghai Ninth People´s Hospital

    Shanghai, China

  • Shanghai Obstetrics and Gynecology Hospital

    Shanghai, China

  • Sotiria General Hospital, 3rd Deúpartment of Medicine, School of Medicine, National and Kapodistrian University of Athens

    Athens, Greece

  • Swiss Medical Network - Clinique de Genolier

    Genolier, Switzerland

  • The Royal Marsden Hospital

    London, United Kingdom

  • Thomayerova nemocnice

    Prague, 14059, Czechia

  • University Hospital Basel

    Basel, Switzerland

  • Universitätsmedizin Mannheim

    Mannheim, Germany

More trials for these conditions

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