RecruitingPhase 4NCT06726291

Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer

Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer Treated With Taxane- Platinum Combination Chemotherapy. NOEME Study.


Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Enrollment

84 participants

Start Date

Feb 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The clinical trial concerns the use of an innovative \"anti-emetic\" drug (that is, anti-vomiting and nausea) in subjects affected by endometrial cancer. It is addressed to patients who have never received chemotherapy before and are about to start a treatment with platinum and taxanes with or without immunotherapy for endometrial cancer. The primary objective of the study is to learn if the drug is able to avoid the occurrence of vomiting and post- nausea chemotherapy within 120 hours after cycle 1 with carboplatin and paclitaxel with or without immunotherapy. Partecipants will take the drug before the chemotherapy/immunotherapy (single dose at day one of each cycle of therapy, that is one capsule before treatment). The entire duration of participation in the study may extend to the fourth cycle of chemotherapy/immunotherapy. Patients will fill in questionnaires and keep a diary of the number and intensity of symptoms (vomiting and nausea).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether Akynzeo (a combination antiemetic drug that prevents nausea and vomiting) is effective and well-tolerated in patients with endometrial (uterine) cancer receiving chemotherapy. **You may be eligible if...** - Age 18 or older - Have confirmed endometrial cancer (diagnosis confirmed by biopsy) - Scheduled to receive chemotherapy for your cancer - Adequate organ function (heart, kidneys, liver) - Able to provide written informed consent **You may NOT be eligible if...** - Have had severe allergic reactions to antiemetic drugs in the past - Have serious liver or kidney problems - Are currently taking medications that strongly interact with Akynzeo - Are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNEPA (300mg netupitant/0.5mg palonosetron)

a single dose (capsule) of NEPA (300mg netupitant/0.5 palonosetron) at day 1 for a maximum of 4 cycles


Locations(8)

ASST Spedali Civili di Brescia

Brescia, BS, Italy

ASST Lecco - A. Manzoni Hospital

Lecco, LC, Italy

Istituto Oncologico Veneto

Padova, PD, Italy

Centro di Riferimento Oncologico (CRO) IRCCS

Aviano, PN, Italy

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, TO, Italy

AOU Città della Salute e della Scienza di Torino

Torino, TO, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Istituto Europeo di Oncologia

Milan, Italy

View Full Details on ClinicalTrials.gov

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NCT06726291


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