Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

About this trial

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 criteria

Qualifiers

Subject is at least 18 years of age, able to understand the study procedures, and agrees to participate in the study by providing written informed consent

Subject has histologically or cytologically proven endometrial cancer

Patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Adequate organ function allowing the patient to receive taxane-platinum combination therapy with or without immunotherapy according to clinical practice and opinion of treating physician

Disqualifiers

They will experience emesis within the 24 hours before receipt of 1 course of chemotherapy

will be scheduled to radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5

Will be scheduled to undergo bone marrow or stem-cell transplant

Chronic systemic corticosteroid use

Trial design

Treatments tested in this trial

  • NEPA (300mg netupitant/0.5mg palonosetron)

Treatment groups

84 Participants
are divided into 1 treatment group