Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery

NCT ID: NCT06530524

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2027-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type: DRUG

Injection of onabotulinumtoxinA into the at-risk major salivary glands

Interventions

OnabotulinumtoxinA

Injection of onabotulinumtoxinA into the at-risk major salivary glands

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lady Davis Institute

OTHER

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: collaborator

Sir Mortimer B. Davis - Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Marco Mascarella

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

McGill University

Montreal, Quebec, Canada

Countries

Canada

Facility Contacts

Marco A Mascarella, MD

Role: primary

marco.mascarella@mcgill.ca

Other Identifiers

PROTOX

Identifier Type: -

Identifier Source: org_study_id