A Phase 4 interventional study of Echo-guided Botox injection and echo-guided normal saline injection in Trismus, Head and Neck Cancer and Radiation Therapy Recipient, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by National Taiwan University Hospital · Phase 4, Interventional, and Treatment
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.
107 studies on the registry are indexed under Trismus; 19 are open to participants now.
This study's planned enrollment of 120 is above the median of 52 across 99 interventional studies indexed under Trismus.
Browse Trismus studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion Criteria:
Drug: Echo-guided Botox injection
Procedure: echo-guided normal saline injection
Echo-guided Botox injection to the masticatory muscles
echo-guided normal saline injection
Maximal Incisal Opening
Time frame: From enrollment to the end of treatment at 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Nov 2025, 11 months after the start.
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