Efficacy of Botox Injection of the Masticatory Muscles in Head &Neck Cancer Patients with Trismus After Radiotherapy
NCT ID: NCT06734598
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
120 participants
INTERVENTIONAL
2024-12-01
2026-02-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Botox injection
Echo-guided Botox injection
Echo-guided Botox injection to the masticatory muscles
Normal Saline Injection
echo-guided normal saline injection
echo-guided normal saline injection
Interventions
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Echo-guided Botox injection
Echo-guided Botox injection to the masticatory muscles
echo-guided normal saline injection
echo-guided normal saline injection
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Dr. Chen
Role: primary
Other Identifiers
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202410133MINA
Identifier Type: -
Identifier Source: org_study_id