Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery

Sir Mortimer B. Davis - Jewish General Hospital

Status and phase: Not yet enrolling; Phase 2

Conditions: Head Neck Cancer; Xerostomia Following Radiotherapy

Treatments: Drug: Placebo; Drug: OnabotulinumtoxinA

Study type: Interventional

Funder types: Other

Identifiers

NCT06530524

PROTOX

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

onabotulinumtoxinA

Experimental group

Description:

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.

Treatment:

Drug: OnabotulinumtoxinA