Botox for Trismus in Head and Neck Cancer Patients
Efficacy of Botox Injection of the Masticatory Muscles in Head &Neck Cancer Patients with Trismus After Radiotherapy
Recruiting
Phase 4
Interventional Study
Trismus
Head and Neck Cancer
Radiation Therapy Recipient
BOTOX
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- National Taiwan University Hospital · Other
Who this trial is looking for
This trial is looking for patients with head and neck cancer who have difficulty opening their mouths after radiation therapy. Participants will receive Botox injections to help relax their jaw muscles and improve mouth opening while also doing oral exercises.
Are You a Good Fit for This Trial?
You may be able to join if
- I am over 18 years old.
- I have completed radiotherapy for head and neck cancer at least 3 months ago.
- I can open my mouth less than or equal to 3.5 cm.
- I have tightness or pain in my jaw muscles.
- My medical condition is stable.
You may not be able to join if
- I have had surgery on my jaw muscles.
- I have significant muscle wasting or scarring in my jaw muscles.
- I have a recurrence of my cancer at this time.
- I have unstable vital signs due to an acute illness.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 exe…
Trial Locations
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Eligibility 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 m…
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