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Not yet recruitingNCT07882966PRÊTUpdated Oct 20, 2026

Prophylaxis for Emetogenic radioTherapy With Akynzeo

A Phase 2 interventional study of Akynzeo in Palliative Cancer, sponsored by University Health Network, Toronto. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Supportive care

Updated Oct 20, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
188
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This phase II, prospective study evaluates whether prophylactic treatment with Akynzeo can reduce nausea and vomiting in patients receiving palliative radiotherapy in which the gastrointestinal GI tract is within the radiation field. Patients undergoing emetogenic palliative radiotherapy will be enrolled and monitored for treatment-related nausea and vomiting. The study hypothesizes that Prophylactic use of Akynzeo will decrease the incidence and severity of these symptoms and improve patient comfort during radiotherapy.

02

Conditions studied

  • Palliative Cancer
03

In context

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,432 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years old
  • Consent/registration on PERa study and selected for PRÊT study
  • Patients with a full list of analgesic and anti-nauseant medications used
  • Patients with the ability to complete the quality-of-life questionnaires
  • KPS ≥40
  • Patients who have planned for radiotherapy in PMCC to at least symptomatic site located in the body trunk between T10-Pelvis anatomical landmarks or if the stomach is within the field borders
  • No planned changes in analgesic within 5 days before and after treatment
  • No planned cytotoxic chemotherapy, radiotherapy or surgery within 5 days before and 7 days after radiotherapy initiation. Oral molecularly targeted agents and immunotherapy are allowed to be continued without interruption or delay.
  • Able to swallow pills
  • The patient provided informed consent to participate in this study

Exclusion criteria

Exclusion Criteria:

  • Patients with major mental or psychiatric impairments
  • Patients receiving brain radiation within 7 days of study intervention
  • Pregnant or breastfeeding (up to one month after the last dose) females.
  • Patients using CYP3A4 inducers within 4 weeks of Akynzeo treatment: Carbamazepine, Phenobarbital, Phenytoin, St. John's wort, Rifampicin, and Pioglitazone
  • Patients using CYP3A4 substrates concurrently with Akynzeo: pimozide, terfenadine, astemizole, or cisapride
  • Patients with hypersensitivity to netupitant/palonosetron drugs or to any ingredient in the formulation or component of the container.
  • Patients who have or likely to develop prolongation of the QT interval. Risk factors include, but are not limited to, a personal or family history of QT prolongation (e.g., congenital long QT syndromes), electrolyte abnormalities or conditions that can lead to electrolyte abnormalities (e.g., eating disorders), cardiac disease (e.g., congestive heart failure, myocardial ischemia, conduction system disease), and bradycardia or bradyarrhythmia. Caution should also be observed in patients taking anti-arrhythmic medicinal products, other medicinal products that lead to QT prolongation or electrolyte abnormalities, or drugs that inhibit the metabolism of netupitant or palonosetron. Hypokalemia, hypocalcemia, and hypomagnesemia should be corrected prior to administration.
  • Patients with suspected or known severe hepatic impairment (Child-Pugh Score >9) and patients with a bilirubin >51.3 µmol/L, albumin \<28 g/L and INR >2.3 from blood works done within 90 days.
  • Patients with suspected or known severe renal impairment (creatine clearance \<30 mL/min per bloodwork done within 90 days), end-stage renal disease or on dialysis.
05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
188 participants (estimated)

Study arms

  • Experimental
    Drug

    Drug: Akynzeo

Interventions

  • DrugAkynzeo

    Akynzeo (1 Capsule PO: 300 mg netupitant/0.5 mg palonosetron) will be given once on the day of and prior to the first fraction of radiotherapy.

06

What researchers measure

Primary outcomes

  1. Incidence of symptomatic nausea and vomiting within 7 days of starting radiotherapy.

    Measured using the NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and the Common Terminology Criteria for Adverse Events (CTCAE) scales.

    Time frame: 7 days

Secondary outcomes

  1. Rate of complete control of nausea and vomiting, quality of life

    Proportion of patients achieving Complete Control of nausea and vomiting during the 5-day peak symptomatic period following the start of radiotherapy, as measured by the Functional Living Index - Emesis (FLIE) at the 1-week follow-up, visit. * Complete control: no increased episodes of nausea or vomiting with no increased use of antiemetic medication from baseline * Partial control: 1-2 increased episodes of nausea or vomiting with no increased use of antiemetic medication compared to baseline. Uncontrolled response: 3 or more increased episodes of nausea or vomiting, or increased use of anti-emetic medication from baseline * Overall control: includes complete and partial control

    Time frame: 7 days

  2. Antiemetic Utilization: Drug Choice, Timing, and Duration

    Assessment of standard-of-care antiemetic prescribing patterns, including the antiemetic agent(s) prescribed, timing of administration relative to radiotherapy initiation, and duration of antiemetic therapy. This outcome evaluates variations in antiemetic management practices.

    Time frame: 7 days

  3. Rate of interruption and discontinuation of RT.

    Time frame: 7 days

  4. Akynzeo related adverse events per CTCAE V5

    Time frame: 7 days

07

Study locations

1 site
  • Princess Margaret Cancer Center
    Toronto, Ontario M5G 2M9, Canada
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2026
First posted
Oct 20, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Nov 1, 2028
CompletionEst.
Nov 1, 2028
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07882966
Responsible party
Sponsor
First posted
Oct 20, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Nov 1, 2028 (estimated)
Completion
Nov 1, 2028 (estimated)
Last update
Oct 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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