Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

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.

More Head and Neck Cancer trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment120 (estimated)
SponsorNational Taiwan University Hospital
Academic / other
Drugs / interventionsradiation
Locations1 site (Taipei)
StatusRecruiting
StartedDecember 1, 2024
Main results expectedNovember 1, 2025
Study endsFebruary 1, 2026
Registry record updatedDecember 16, 2024
Trial IDNCT06734598 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.