Using Botox to treat jaw stiffness in head and neck cancer patients after radiation
Official title: Efficacy of Botox Injection of the Masticatory Muscles in Head &Neck Cancer Patients with Trismus After Radiotherapy
Run by National Taiwan University Hospital · NCT06734598 · Data updated 2026-11-12
This study is testing if Botox injections can help head and neck cancer patients who have jaw stiffness after radiation therapy feel better and open their mouths more easily.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Taipei) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | November 1, 2025 |
| Study ends | February 1, 2026 |
| Registry record updated | December 16, 2024 |
| Trial ID | NCT06734598 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old who have completed radiotherapy for head and neck cancer at least 3 months prior and have a mouth-opening distance of 3.5 cm or less.
✕Probably not a fit
Patients who have undergone surgery on their masticatory muscles or have significant muscle atrophy or tumor recurrence may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project investigates the effectiveness of Botulinum toxin (Botox) injections into the masticatory muscles of head and neck cancer patients who experience trismus following radiation therapy. The intervention involves echo-guided injections of Botox, combined with oral rehabilitation exercises, aimed at alleviating muscle tension and spasms. The study will evaluate improvements in mouth opening range, quality of life, trismus severity, and pain levels to assess the treatment's efficacy.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from trismus after cancer treatment.
How similar studies have gone: Other studies have shown promising results using Botox for similar conditions, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
National Taiwan University Hospital
Taipei, Taiwan Recruiting
Study contacts
- Study coordinator: Dr. Chen
- Email: b00401020@ntu.edu.tw
- Phone: +88623123456
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.