Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery

Pretherapy Botulinum Toxin to Reduce Radiation-related Xerostomia in Head and Neck Cancer

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06530524

Enrollment

Registered

2024-07-31

Start date

2024-10-01

Completion date

2027-12-01

Last updated

2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Neck Cancer, Xerostomia Following Radiotherapy

Keywords

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

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.

Interventions

DRUGOnabotulinumtoxinA

Injection of onabotulinumtoxinA into the at-risk major salivary glands

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026