Status:

RECRUITING

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

Lead Sponsor:

National Taiwan University Hospital

Conditions:

Trismus

Head and Neck Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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 mu...

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.

Key Trial Info

Start Date :

December 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2026

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT06734598

Start Date

December 1 2024

End Date

February 1 2026

Last Update

December 16 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

National Taiwan University Hospital

Taipei, Taiwan, 100415

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