A Simplified Regimen to Prevent Nausea and Vomiting Using Netupitant/Palonosetron in Germ Cell Cancer Patients Receiving Chemotherapy
NCT07662200 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-06-23
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.
Conditions
- Germ Cell Cancer
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
-
Daily by mouth for 7 days (12mg on the first day, 8mg on subsequent days)
- DRUG
-
5mg taken at night by mouth for 7 days
Sponsors & Collaborators
-
Ottawa Hospital Research Institute
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2027-08-31
- Completion
- 2028-08-31
Countries
- Canada
Study Locations
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