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NOT YET RECRUITING
NCT07662200
EARLY_PHASE1

A Simplified Regimen to Prevent Nausea and Vomiting Using Netupitant/Palonosetron in Germ Cell Cancer Patients Receiving Chemotherapy

Sponsor: Ottawa Hospital Research Institute

View on ClinicalTrials.gov

Summary

This is a single-site, open-label, randomized pilot feasibility study conducted at The Ottawa Hospital Cancer Centre. A total of 10 participants will be randomized 1:1 to either the experimental or control arm. The purpose of this study is to evaluate recruitment capability, intervention adherence, data completeness, and safety prior to consideration of a potential future multi-centre randomized trial.

Official title: A Pilot Feasibility Study of a Steroid-Sparing Anti-Nausea and Vomiting Regimen With Netupitant/Palonosetron for Patients With Germ Cell Tumours Receiving Multi-Day Cisplatin-Based Chemotherapy at The Ottawa Hospital

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-08

Completion Date

2028-08

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

DRUG

Netupitant/Palonosetron Hydrochloride

300mg/0.5mg combination pill taken once daily by mouth on the first and third day of chemotherapy

DRUG

Ondansetron (Control)

8mg taken twice daily by mouth for 5 days

DRUG

Aprepitant

Daily by mouth on the first (125mg), third (80mg), and fifth (80mg) day

DRUG

Dexamethasone

Daily by mouth for 7 days (12mg on the first day, 8mg on subsequent days)

DRUG

Olanzapine

5mg taken at night by mouth for 7 days

Locations (1)

Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada