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RECRUITING
NCT06726291
PHASE4

Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer

Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

View on ClinicalTrials.gov

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).

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2024-02-26

Completion Date

2026-06-30

Last Updated

2024-12-10

Healthy Volunteers

No

Interventions

DRUG

NEPA (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