A Simplified Regimen to Prevent Nausea and Vomiting Using Netupitant/Palonosetron in Germ Cell Cancer Patients Receiving Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Netupitant/Palonosetron Hydrochloride, Ondansetron (Control), Aprepitant, Dexamethasone.
- Who it may be relevant to
- Registry conditions: Germ Cell Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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
Primary outcome measures
- Feasibility of study [Time frame: Through study completion, up to 1 year]
Secondary outcome measures (4)
- Complete Response (CR) [Time frame: After Cycle 1 (Each cycle is 7 days)]
- Early Complete Response, late Complete Response and total control [Time frame: 1 year]
- Review toxicities [Time frame: 1 year]
- Quality of Life outcomes [Time frame: 1 year]
Eligibility criteria
- Diagnosis of germ cell cancer
- Indication for outpatient treatment using a standard 5-day cisplatin-based chemotherapy regimen
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Canada · 1 center
- Ottawa Hospital Cancer Centre — Ottawa
Identifiers
NCT: NCT07662200 · OHRI SPARROW-GC