Clinical Trial

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

Recruiting Phase 4
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Record status
This record was last updated December 16, 2024 (before its estimated November 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06734598
Lead Sponsor National Taiwan University Hospital
Conditions Trismus, Head and Neck Cancer, Radiation Therapy Recipient, BOTOX
Enrollment 120 participants
Start Date 2024-12-01
Primary Completion 2025-11-01 (estimated)
Study Completion 2026-02-01 (estimated)
Updated on ClinicalTrials.gov 2024-12-16