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NCT Number: NCT06530524

Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery

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.

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Key information

Conditions

Head Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Xerostomia Following Radiotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

McGill University

Montreal, Quebec, Canada

Location contact

Marco A Mascarella, MD

CONTACT

[email protected]

Marco A Mascarella, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous radiation to the head and neck
  • Previous treatment for head and neck cancer
  • Personal history of xerostomia
  • Hypersensitivity to onabotulinumtoxinA
  • Previous major salivary gland surgery
  • Previous exposure to radioactive iodine therapy

Treatment and study plan

OnabotulinumtoxinA

Drug

Injection of onabotulinumtoxinA into the at-risk major salivary glands

Placebo

Drug

Injection of normal saline into the at-risk major salivary glands

Primary outcomes

  1. Xerostomia-related quality of life

    Time frame: Pretreatment, 6 and 12 months from treatment completion

    University of Washington Quality of Life questionnaire (higher score is better)

Secondary outcomes

  1. Unstimulated salivary function using salivary gland scintigraphy

    Time frame: Pretreatment and 12 months from treatment completion

    Measurement of unstimulated salivary gland flow prior to initiation of therapy and at 12 months from completion of therapy

Sponsors and collaborators

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Other

Collaborators

  • Lady Davis Institute
  • McGill University Health Centre/Research Institute of the McGill University Health Centre

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 31, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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