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NCT Number: NCT06734598

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

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.

Recruiting

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Key information

Conditions

Trismus Botox Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Radiation Therapy Recipient Signs and Symptoms Spasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged over 18 years old;
  • Head and neck cancer patients must have completed radiotherapy for at least 3 months;
  • 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;
  • Medical condition is stable;

Exclusion criteria

  • Those who have undergone surgery on their masticatory muscles;
  • Patients with obvious muscle atrophy or complete fibrosis of masticatory muscles ;
  • Those with tumor recurrence at the time of admission;
  • Those whose vital signs are unstable due to acute illness.

Treatment and study plan

Echo-guided Botox injection

Drug

Echo-guided Botox injection to the masticatory muscles

echo-guided normal saline injection

Procedure

echo-guided normal saline injection

Primary outcomes

  1. Maximal Incisal Opening

    Time frame: From enrollment to the end of treatment at 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Chen

CONTACT

[email protected]

+88623123456

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 16, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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