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Phase 4
Age: 18Years +
FEMALE
ID06726291

Study of NEPA Netupitant and Palonosetron to Prevent Nausea and Vomiting in Adult Women With Endometrial Cancer Undergoing Taxane-Platinum Chemotherapy With or Without Immunotherapy

Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2024-12-10

84

Participants Needed

8

Research Sites

25 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying an anti-nausea and anti-vomiting drug called NEPA in women with endometrial cancer who have not received chemotherapy before and are about to start treatment with carboplatin and paclitaxel, with or without immunotherapy. The study aims to see if this drug can prevent vomiting and nausea within 120 hours after the first chemotherapy cycle. It also looks at how nausea and other chemotherapy side effects affect quality of life, daily activities, and personal relationships. Participants will take a single oral dose of NEPA a combination of netupitant and palonosetron as one capsule before each chemotherapy or immunotherapy cycle, for up to four cycles. This phase IV, multicenter, single-arm study focuses on patients receiving taxane-platinum combination therapy, either as first-line treatment or in the adjuvant setting. The main evaluation will occur after the first cycle. During the study, patients will complete questionnaires and keep diaries to record the number and severity of vomiting and nausea episodes. Researchers will assess the drugs effectiveness in preventing these symptoms over the first 120 hours after treatment, along with safety and quality of life during each cycle. Participation may last through four treatment cycles, and patients symptom reports will be compared with clinical assessments throughout the study.

CONDITIONS

Brief Title

Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer

Research Team

M

Monika Ducceschi, MD

M

Mara Mantiero, MD

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