Efficacy of Botox Injection of the Masticatory Muscles in Head &Neck Cancer Patients with Trismus After Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Echo-guided Botox injection, echo-guided normal saline injection.
- Who it may be relevant to
- Registry conditions: Trismus, Head and Neck Cancer, Radiation Therapy Recipient, BOTOX. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Echo-guided Botox injection
Echo-guided Botox injection to the masticatory muscles - Procedure echo-guided normal saline injection
echo-guided normal saline injection
Primary outcome measures
- Maximal Incisal Opening [Time frame: From enrollment to the end of treatment at 6 months]
Eligibility criteria
Inclusion criteria
- Aged over 18 years old;
- Head and neck cancer patients must have completed radiotherapy for at least 3 months;
- 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;
- Medical condition is stable;
Exclusion criteria
- Those who have undergone surgery on their masticatory muscles;
- Patients with obvious muscle atrophy or complete fibrosis of masticatory muscles ;
- Those with tumor recurrence at the time of admission;
- Those whose vital signs are unstable due to acute illness.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT06734598 · 202410133MINA