Dexamethasone-sparing Approach Including NEPA Against Emesis Caused by Cisplatin — LUNG-NEPA  

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title: A Standard Regimen of Dexamethasone in Comparison to Two Dex-sparing Regimens in Addition to NEPA in Preventing CINV in naïve NSCLC Patients to be Treated With Cisplatin Based Chemotherapy: a Three-arm, Open-label, Randomized Study

Status Active, not recruiting

Clinical Trial Summary

This study evaluates the possibility to reduce the total dose of dexamethasone, when administered with NEPA, to prevent chemotherapy-induced nausea and vomiting (CINV) in Non-Small Cell Lung Cancer (NSCLC) patients receiving a cisplatin-based chemotherapy

Clinical Trial Description

On day 1 (day of chemotherapy), all eligible patients will receive oral NEPA (300 mg netupitant/0.5 mg palonosetron), 60 minutes before chemotherapy, and intravenous dexamethasone 12 mg, 30 minutes before chemotherapy initiation.

For the prevention of delayed CINV, patients will be assigned randomly to one of the following treatment arms:

• Test arm A: no further anti-emetic prophylaxis on days 2 thorough 4;

• Test arm B: oral dexamethasone 4 mg once per day in the morning of days 2 and 3;

• Reference arm C: oral dexamethasone 4 mg twice per day on days 2 thorough 4. ;

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

• NCT number: NCT04201769
• Study type: Interventional
• Source: Consorzio Oncotech
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 25, 2016
• Completion date: April 2020