RecruitingPhase 4NCT06734598

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


Sponsor

National Taiwan University Hospital

Enrollment

120 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting Botox (botulinum toxin) into the jaw muscles can help head and neck cancer patients who developed trismus — difficulty opening their mouth — as a side effect of radiation therapy. **You may be eligible if...** - You are over 18 years old - You are a head and neck cancer patient who finished radiation therapy at least 3 months ago - You can open your mouth less than 3.5 cm wide and experience tightness or pain in your jaw muscles - Your cancer is not currently active (stable medical condition) **You may NOT be eligible if...** - You have had surgery on your jaw muscles - Your jaw muscles are severely wasted or completely scarred - Your cancer has come back - Your vital signs are unstable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEcho-guided Botox injection

Echo-guided Botox injection to the masticatory muscles

PROCEDUREecho-guided normal saline injection

echo-guided normal saline injection


Locations(1)

National Taiwan University Hospital

Taipei, Taiwan

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NCT06734598


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