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: Recruiting
• Conditions: Head and Neck Cancer; Trismus; Radiation Therapy Recipient; BOTOX
• Intervention / Treatment: Drug: Echo-guided Botox injection; Procedure: echo-guided normal saline injection

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dr. Chen; Phone Number: +88623123456; Email: b00401020@ntu.edu.tw

Study Locations

• Taiwan
  • 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: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botox injection	Drug: Echo-guided Botox injection; Echo-guided Botox injection to the masticatory muscles
Placebo Comparator: Normal Saline Injection	Procedure: echo-guided normal saline injection; echo-guided normal saline injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximal Incisal Opening	From enrollment to the end of treatment at 6 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Neoplasms by Site; Neoplasms; Spasm; Head and Neck Neoplasms; Trismus
• Other Study ID Numbers: 202410133MINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No