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Trial Title:
Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery
NCT ID:
NCT06530524
Condition:
Head Neck Cancer
Xerostomia Following Radiotherapy
Conditions: Official terms:
Head and Neck Neoplasms
Xerostomia
Botulinum Toxins, Type A
abobotulinumtoxinA
Conditions: Keywords:
Head and Neck Cancer
Radiation induce xerostoma
botulinum toxin
salivary glands
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
OnabotulinumtoxinA
Description:
Injection of onabotulinumtoxinA into the at-risk major salivary glands
Arm group label:
onabotulinumtoxinA
Intervention type:
Drug
Intervention name:
Placebo
Description:
Injection of normal saline into the at-risk major salivary glands
Arm group label:
Placebo
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
McGill University
Address:
City:
Montreal
Country:
Canada
Contact:
Last name:
Marco A Mascarella, MD
Email:
marco.mascarella@mcgill.ca
Investigator:
Last name:
Marco A Mascarella, MD
Email:
Principal Investigator
Start date:
October 1, 2024
Completion date:
December 1, 2027
Lead sponsor:
Agency:
Sir Mortimer B. Davis - Jewish General Hospital
Agency class:
Other
Collaborator:
Agency:
Lady Davis Institute
Agency class:
Other
Collaborator:
Agency:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Agency class:
Other
Source:
Sir Mortimer B. Davis - Jewish General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06530524
