NCT06734598

Efficacy of Botox Injection of the Masticatory Muscles in Head &Neck Cancer Patients with Trismus After Radiotherapy

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Trismus is a common side effect in head and neck cancer patients after radiation therapy. This project aims to explore the therapeutic effect of Botulinum toxin (Botox) injection to the masticatory muscles in the above-mentioned patients. In this project, Botulinum toxin will be injected into the masticatory muscles (medial pterygoid and masticatory muscles), combined with oral rehabilitation exercises, to reduce the patient's masticatory muscle tension and spasm. Patient's mouth opening range, quality of life, trismus condition and pain will be evaluated to understand its efficacy.

Conditions

• Trismus
• Head and Neck Cancer
• Radiation Therapy Recipient
• BOTOX

Interventions

Type	Name	Description
DRUG	Echo-guided Botox injection	Echo-guided Botox injection to the masticatory muscles
PROCEDURE	echo-guided normal saline injection	echo-guided normal saline injection

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-11-01
• Completion: 2026-02-01
• First posted: 2024-12-16
• Last updated: 2024-12-16

Locations

1 site across 1 country: Taiwan