MedDataX Logo

Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery

NCT ID: NCT06530524

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head Neck Cancer Xerostomia Following Radiotherapy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Head and Neck Cancer Radiation induce xerostoma botulinum toxin salivary glands

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Meet the organizations funding or collaborating on the study and learn about their roles.

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

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marco Mascarella

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

McGill University

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marco A Mascarella, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PROTOX

Identifier Type: -

Identifier Source: org_study_id