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:
- 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.
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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1
National Taiwan University Hospital
Taipei, Taiwan, 100415