Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery

Launched by SIR MORTIMER B. DAVIS - JEWISH GENERAL HOSPITAL · Jul 26, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help patients with head and neck cancer avoid a common side effect of radiation treatment called xerostomia, or dry mouth. After radiation therapy, many patients experience severe dry mouth, which can be uncomfortable and affect their quality of life. The researchers want to see if injecting a substance called botulinum toxin into the salivary glands before radiation can help protect those glands and keep them functioning better during treatment.

To be eligible for this study, participants need to be newly diagnosed with a specific type of advanced head and neck cancer that requires radiation therapy. However, those who have had previous radiation to the head and neck or certain other treatments will not be included. The trial is not yet recruiting participants, but once it starts, those who qualify will receive the botulinum toxin injection before starting their radiation therapy. This could potentially lead to less severe dry mouth and improve their overall treatment experience.

Gender

ALL

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