Clinical trial · Interventional
A Simplified Regimen to Prevent Nausea and Vomiting Using Netupitant/Palonosetron in Germ Cell Cancer Patients Receiving Chemotherapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Germ Cell Cancer | Malignant Germ Cell Tumor | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aprepitant | Drug | — | UNRESOLVED |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Netupitant/Palonosetron Hydrochloride | Drug | — | UNRESOLVED |
| Olanzapine | Drug | — | UNRESOLVED |
| Ondansetron (Control) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1
- description
- 1. Ondansetron 8mg taken twice daily by mouth for 5 days 2. Aprepitant taken daily by mouth on the first (125mg), third (80mg), and fifth (80mg) day. 3. Dexamethasone taken daily by mouth for 7 days (12mg on the first day, 8mg on subsequent days) 4. Olanzapine 5mg taken at night by mouth for 7 days
- interventionNames
- Drug: Ondansetron (Control)
- Drug: Aprepitant
- Drug: Dexamethasone
- Drug: Olanzapine
- type
- EXPERIMENTAL
- label
- Group 2
- description
- 1. Netupitant/Palonosetron\* (300mg/0.5mg) combination pill taken once daily by mouth on the first and third day of chemotherapy 2. Dexamethasone 4mg taken once daily by mouth for 5 days 3. Olanzapine 5mg taken at night by mouth for 7 days
- interventionNames
- Drug: Netupitant/Palonosetron Hydrochloride
- Drug: Dexamethasone
- Drug: Olanzapine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
1. Diagnosis of germ cell cancer 2. Indication for outpatient treatment using a standard 5-day cisplatin-based chemotherapy regimen
References
Publications (0)
Data not yet available