Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery

Phase 2

Not yet recruiting

• Conditions: Head Neck Cancer; Xerostomia Following Radiotherapy
• Interventions: Drug: Placebo; Drug: OnabotulinumtoxinA

• Registration Number: NCT06530524
• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Study Start: 2024-10-01
• Primary Completion: 2026-10-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
onabotulinumtoxinA	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Unstimulated salivary function using salivary gland scintigraphy	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

Trial Locations

Locations (1)

McGill University; 🇨🇦 Montreal, Quebec, Canada