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A Simplified Regimen to Prevent Nausea and Vomiting Using Netupitant/Palonosetron in Germ Cell Cancer Patients Receiving Chemotherapy

ConditionGerm Cell Cancer
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of germ cell cancer

Indication for outpatient treatment using a standard 5-day cisplatin-based chemotherapy regimen

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Netupitant/Palonosetron Hydrochloride

    Drug

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

  • Ondansetron (Control)

    Drug

    8mg taken twice daily by mouth for 5 days

  • Aprepitant

    Drug

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

  • Dexamethasone

    Drug

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

  • Olanzapine

    Drug

    5mg taken at night by mouth for 7 days

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Group 1Active comparator 4 interventions
Group B: Group 2Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Feasibility of study

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.

Time frame
Through study completion, up to 1 year

Secondary outcomes

1

Complete Response (CR)

To evaluate the CR after Cycle 1

Time frame
After Cycle 1 (Each cycle is 7 days)
2

Early Complete Response, late Complete Response and total control

To evaluate the response at the end of the study

Time frame
1 year
3

Review toxicities

Describe patient-reported toxicities using PRO-CTCAE

Time frame
1 year
4

Quality of Life outcomes

Describe the quality of life outcomes using the Functional Living Index Emesis (FLIE)

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Hospital Research Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: