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

Status

Not yet recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07662200

Acronym

SPARROW-GC

Enrollment

Registered

2026-06-23

Start date

2026-08-01

Completion date

2028-08-01

Last updated

2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Germ Cell Cancer

Keywords

SPARROW-GC, Netupitant, Palonosetron, Steroid-Sparing Anti-Nausea and Vomiting Regimen

Brief 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.

Interventions

DRUGNetupitant/Palonosetron Hydrochloride

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

DRUGOndansetron (Control)

8mg taken twice daily by mouth for 5 days

DRUGAprepitant

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

DRUGDexamethasone

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

DRUGOlanzapine

5mg taken at night by mouth for 7 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Diagnosis of germ cell cancer 2. Indication for outpatient treatment using a standard 5-day cisplatin-based chemotherapy regimen

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of study	Through study completion, up to 1 year	To measure the feasibility of the study, the researchers will collect the recruitment rate, the consent rate among eligible patients, the completion of symptom and quality-of-life assessments, the adherence to protocol, the frequency of protocol deviations and safety events.

Secondary

Measure	Time frame	Description
Complete Response (CR)	After Cycle 1 (Each cycle is 7 days)	To evaluate the CR after Cycle 1
Early Complete Response, late Complete Response and total control	1 year	To evaluate the response at the end of the study
Review toxicities	1 year	Describe patient-reported toxicities using PRO-CTCAE
Quality of Life outcomes	1 year	Describe the quality of life outcomes using the Functional Living Index Emesis (FLIE)

Countries

Canada

Contacts

CONTACTDominick Bossé, M.D.

dbosse@toh.ca1-613-737-7700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026