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Search / Trial NCT06734598

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

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Dec 12, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the use of Botox injections in patients who have head and neck cancer and are experiencing trismus, which is a condition that makes it difficult to open the mouth after radiation therapy. The goal is to see if Botox can help relax the tight muscles in the jaw, making it easier for patients to open their mouths, improve their quality of life, and reduce pain. Participants will receive Botox injections and will also do oral rehabilitation exercises to support their recovery.

To be eligible for this trial, participants must be over 18 years old, have completed their radiation therapy for at least three months, and have a limited mouth-opening distance of 3.5 cm or less, along with muscle tightness or pain. Importantly, the patient's overall health should be stable. Those who have had surgery on their jaw muscles or have certain other medical conditions are not eligible. If you join this trial, you can expect regular evaluations to measure your progress and overall well-being during the study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Aged over 18 years old;
  • 2. Head and neck cancer patients must have completed radiotherapy for at least 3 months;
  • 3. Those whose mouth-opening distance is less than or equal to 3.5 cm (the functional cut-off point of trismus) and who have tightness or pain in the masticatory muscles;
  • 4. Medical condition is stable;
  • Exclusion Criteria:
  • 1. Those who have undergone surgery on their masticatory muscles;
  • 2. Patients with obvious muscle atrophy or complete fibrosis of masticatory muscles ;
  • 3. Those with tumor recurrence at the time of admission;
  • 4. Those whose vital signs are unstable due to acute illness.

About National Taiwan University Hospital

National Taiwan University Hospital (NTUH) is a leading medical institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a pioneer in medical education and patient care in Taiwan, NTUH integrates cutting-edge technology with comprehensive clinical expertise to facilitate groundbreaking studies across various medical fields. The hospital’s dedicated research team collaborates with local and international partners to enhance the understanding of diseases and improve treatment outcomes. By prioritizing patient safety and ethical standards, NTUH strives to contribute to the global medical community and foster advancements in healthcare practices.

Locations

Taipei City, , Taiwan

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported