Efficacy of Botox Injection of the Masticatory Muscles in Head &Neck Cancer Patients with Trismus After Radiotherapy
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Dr. Chen
- Phone Number: +88623123456
- Email: b00401020@ntu.edu.tw
Study Locations
-
-
-
Taipei City, Taiwan, 100415
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Dr. Chen
- Phone Number: +886-2312-3456
- Email: b00401020@ntu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Botox injection
|
Echo-guided Botox injection to the masticatory muscles
|
|
Placebo Comparator: Normal Saline Injection
|
echo-guided normal saline injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Maximal Incisal Opening
Time Frame: From enrollment to the end of treatment at 6 months
|
From enrollment to the end of treatment at 6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202410133MINA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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