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NCT06530524Not yet recruitingPhase 2

Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery

Pretherapy Botulinum Toxin to Reduce Radiation-related Xerostomia in Head and Neck Cancer

Source: ClinicalTrials.gov · Last updated 31 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Head and neck cancer care, including tumors of the mouth, nose, throat and voice box, often requires radiation for cure to be achieved. Despite advances in radiation, 40% to 60% of patients experience a significant dry mouth (xerostomia) following radiotherapy. Several factors are associated with severe xerostomia including older age, advanced stage disease and tumor location. Currently, no pragmatic treatment strategy exists to reduce the risk of radiation-related xerostomia in patients with head and neck cancer. The investigators propose the use of a botulinum neurotoxin injected into the at-risk salivary glands before radiation as a strategy to preserve salivary gland function during radiation treatments and reduce xerostomia.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
50 (estimated)
First submitted
23 Jul 2024
Start date
1 Oct 2024
Primary completion date
1 Oct 2026
Lead sponsor
Sir Mortimer B. Davis - Jewish General Hospital
NCT number
NCT06530524

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 50
  • From 1 Oct 2024 to the primary completion date, 1 Oct 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous radiation to the head and neck
  • Previous treatment for head and neck cancer
  • Previous major salivary gland surgery
  • Previous exposure to radioactive iodine therapy

Other illness

  • Personal history of xerostomia
  • Hypersensitivity to onabotulinumtoxinA

Who the study is looking for

  • Newly diagnosis AJCC 8th edition Stage III/IVa mucosal head and neck squamous cell carcinoma requiring definitive radiotherapy (with or without chemotherapy).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
McGill University
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.