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Could a common Anti-Nausea pill change how chemo works?

NCT ID NCT03514381

Knowledge-focused Sponsor: Institut Claudius Regaud 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 59 people with soft tissue sarcoma who were getting chemotherapy with doxorubicin and ifosfamide. Researchers wanted to see if adding the anti-nausea drug aprepitant changed the amount of ifosfamide in the blood. Patients had blood samples taken during their first chemo cycle (without aprepitant) and second cycle (with aprepitant). The goal was to understand any drug interaction that could affect treatment safety or effectiveness.

What this could mean

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

Active substance
aprepitant (anti-nausea drug) and ifosfamide (chemotherapy)
What this could lead to
If successful, this could help doctors adjust chemotherapy dosing when using aprepitant, potentially reducing side effects.
What could go wrong
This is a small, completed Phase 4 study focused on drug levels, not on curing sarcoma. It may not lead to changes in treatment guidelines.

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

59 people

The number who actually took part.

Started

May 2018

Finished

Nov 2020

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

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. Age ≥ 18 years. 2. Anatomopathologic diagnosis of soft tissue sarcoma (localized, local recidive or metastatic). 3. Patient receiving doxorubicin and ifosfamide chemotherapy (treatment decided during Multidisciplinary consultation meetings) (neoadjuvant, adjuvant or palliative treatment). 4. Screening laboratory values must meet the following criteria: 1. Hemoglobin \> 9.0 g/dL, Neutrophils \> 1500/mm3, Platelets \> 100000/mm3 2. Creatinine clearance (MDRD formula) \> 60ml/min. 3. AST/ALT \< 2.5 x ULN (5 x ULN in patients with hepatic metastasis). 5. Evaluable disease (measurable per RECIST or not), if applicable. 6. Patient must provide written informed consent prior to any study specific procedures. 7. Patient affiliated to a Social Health Insurance in France. Exclusion Criteria: 1. Previous treatment with Ifosfamide. 2. Patient who has already started doxorubicin and ifosfamide treatment. 3. Any medical condition that can increase the patient's risk 1. Active infection 2. Active hepatitis or cirrhosis 3. Recipients of organ transplants or immunocompromised patients, including Human Immunodeficiency Virus (HIV) infection 4. Pregnant or breastfeeding women 5. Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure 6. Patient protected by law

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Conditions

The condition(s) this trial relates to.

sarcoma soft tissue sarcoma

As listed by the trial registrant

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

Soft tissue sarcoma

Contacts and locations

Locations

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Regional Du Cancer de Montpellier (Icm)

    Montpellier, 34298, France

  • Institut Universitaire Du Cancer de Toulouse - Oncopole

    Toulouse, 31059, France

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