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

No results posted yet for this study

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

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07662200 on ClinicalTrials.gov