Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06734598

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

Led by National Taiwan University Hospital · Updated on 2024-12-16

120

Participants Needed

1

Research Sites

61 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged over 18 years old
  • Head and neck cancer patients who completed radiotherapy at least 3 months ago
  • Mouth opening distance less than or equal to 3.5 cm with tightness or pain in the masticatory muscles
  • Stable medical condition
Not Eligible

You will not qualify if you...

  • Previous surgery on masticatory muscles
  • Obvious muscle atrophy or complete fibrosis of masticatory muscles
  • Tumor recurrence at the time of admission
  • Unstable vital signs due to acute illness

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan, 100415

Actively Recruiting

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Research Team

D

Dr. Chen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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