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

Last updated: December 12, 2024
Sponsor: National Taiwan University Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Head And Neck Cancer

Nasopharyngeal Cancer

Human Papilloma Virus (Hpv)

Treatment

Echo-guided Botox injection

echo-guided normal saline injection

Clinical Study ID

NCT06734598
202410133MINA
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Aged over 18 years old;

  2. Head and neck cancer patients must have completed radiotherapy for at least 3months;

  3. Those whose mouth-opening distance is less than or equal to 3.5 cm (the functionalcut-off point of trismus) and who have tightness or pain in the masticatory muscles;

  4. Medical condition is stable;

Exclusion

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.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Echo-guided Botox injection
Phase: 4
Study Start date:
December 01, 2024
Estimated Completion Date:
February 01, 2026

Connect with a study center

  • National Taiwan University Hospital

    Taipei City, 100415
    Taiwan

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.