Efficacy of Botox Injection of the Masticatory Muscles in Head &Neck Cancer Patients with Trismus After Radiotherapy

NCT06734598 | Recruiting Phase 4 DMC

• 1 other identifier: 202410133MINA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trismus; Head and Neck Cancer; Radiation Therapy Recipient; BOTOX

Outcome Measures

Primary Outcomes (1)

• Maximal Incisal Opening

  From enrollment to the end of treatment at 6 months

Study Arms (2)

Botox injection

EXPERIMENTAL

Drug: Echo-guided Botox injection

Normal Saline Injection

PLACEBO COMPARATOR

Procedure: echo-guided normal saline injection

Interventions

Echo-guided Botox injection DRUG

Echo-guided Botox injection to the masticatory muscles

Botox injection

echo-guided normal saline injection PROCEDURE

echo-guided normal saline injection

Normal Saline Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100415, Taiwan

RECRUITING

MeSH Terms

Conditions

Trismus; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms

Central Study Contacts

Dr. Chen

CONTACT

+88623123456; b00401020@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 16, 2024
• Study Start: December 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)