Using Botox to treat jaw stiffness in head and neck cancer patients after radiation
Efficacy of Botox Injection of the Masticatory Muscles in Head &Neck Cancer Patients with Trismus After Radiotherapy
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 |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06734598 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promising results using Botox for similar conditions, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Dr. Chen
- Email: b00401020@ntu.edu.tw
- Phone: +88623123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.