NCT04201769

Dexamethasone-sparing Approach Including NEPA Against Emesis Caused by Cisplatin

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: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Consorzio Oncotech · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Chemotherapy-induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Netupitant/Palonosetron	NEPA is adiministered 60 minutes before chemotherapy, on day 1
DRUG	Dexamethasone	Intravenous dexamethasone 12 mg is administered 30 minutes before chemotherapy initiation, on day 1. The administration of DEX in the subsequent days (2-4) depends on the randomly assignement to treatment arm

Timeline

• Start date: 2016-11-25
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2019-12-17
• Last updated: 2020-04-03

Locations

26 sites across 1 country: Italy