Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery

NCT06530524 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: PROTOX
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head Neck Cancer; Xerostomia Following Radiotherapy

Keywords

Head and Neck Cancer; Radiation induce xerostoma; botulinum toxin; salivary glands

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Unstimulated salivary function using salivary gland scintigraphy

  Pretreatment and 12 months from treatment completion

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

onabotulinumtoxinA

EXPERIMENTAL

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

Interventions

OnabotulinumtoxinA DRUG

Injection of onabotulinumtoxinA into the at-risk major salivary glands

onabotulinumtoxinA

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

McGill University

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 31, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)