Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Head Neck Cancer; Xerostomia Following Radiotherapy
• Intervention / Treatment: Drug: Placebo; Drug: OnabotulinumtoxinA

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • McGill University
      • Contact: Marco A Mascarella, MD; Email: marco.mascarella@mcgill.ca
      • Principal Investigator: Marco A Mascarella, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; The treating physician will perform the injection of normal saline under ultrasound guidance using a 30-gauge needle introduced into the salivary gland tissue. 30 units of normal saline will be infiltrated the major salivary glands at-risk.	Drug: Placebo; Injection of normal saline into the at-risk major salivary glands
Experimental: onabotulinumtoxinA; The treating physician will perform the injection of onabotulinumtoxinA under ultrasound guidance using a 30-gauge needle introduced into the salivary gland tissue. 30 units of onabotulinumtoxinA will be infiltrated the major salivary glands at-risk.	Drug: OnabotulinumtoxinA; Injection of onabotulinumtoxinA into the at-risk major salivary glands

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Xerostomia-related quality of life	University of Washington Quality of Life questionnaire (higher score is better)	Pretreatment, 6 and 12 months from treatment completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unstimulated salivary function using salivary gland scintigraphy	Measurement of unstimulated salivary gland flow prior to initiation of therapy and at 12 months from completion of therapy	Pretreatment and 12 months from treatment completion

Collaborators and Investigators

• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre; Lady Davis Institute

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; botulinum toxin; salivary glands; Radiation induce xerostoma
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Head and Neck Neoplasms; Xerostomia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: PROTOX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes