Exercise Therapy and Jaw-Mobilizing Device for Trismus in Head and Neck Cancer Patients

Not Applicable

Completed

• Conditions: Head and Neck Cancers; Trismus; Radiotherapy Side Effects

• Registration Number: NCT06719388
• Lead Sponsor: Taipei Medical University

Brief Summary

This study evaluates the effects of exercise therapy combined with a jaw-mobilizing device on enhancing quality of life in head and neck cancer patients undergoing radiotherapy.

Detailed Description

This study investigates the efficacy of exercise therapy combined with a jaw-mobilizing device (ET-JMD) in improving maximal mouth opening (MMO), preventing trismus, enhancing quality of life (QoL), and alleviating trismus-related symptoms in head and neck cancer (HNC) patients undergoing radiotherapy.

Study Timeline

• Study Start: 2021-12-01
• Primary Completion: 2023-06-30
• Study Completion: 2024-10-31
• Study First Submitted: 2024-11-28
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Age ≥ 20 years.
• Ability to communicate in Mandarin or Taiwanese, without significant reading, hearing, or writing impairments, and capable of completing questionnaires independently or with researcher assistance.
• Diagnosed with head and neck cancer and scheduled for initial radiotherapy to the head and neck region.
• Clear consciousness without severe cognitive or psychiatric disorders.
• Presence of intact central incisors (#11, #41) on the right side or (#21, #31) on the left side of both the upper and lower jaws.
• Baseline maximal mouth opening (MMO) ≥ 25 mm.
• Willingness to participate in the study with signed informed consent.

Exclusion Criteria

• Known temporomandibular joint disorders.
• Postoperative wound healing complications diagnosed by a physician that prevent participation in mouth-opening rehabilitation exercises.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maximal Mouth Opening	Baseline to Week 36	Change in Maximal Mouth Opening (MMO) from Baseline to Week 36. higher score means worse.

Secondary Outcome Measures

Name	Time	Method
Quality of Life Scores	Baseline to Week 36	Change in Quality of Life Scores (EORTC QLQ-H\&N35) from Baseline to Week 36. higher score means good quality.
Trismus-Related Symptom Distress Scores	Baseline to Week 36	Change in Trismus-Related Symptom Distress Scores (GTQ2) from Baseline to Week 36. higher score means worse.

Trial Locations

Locations (1)

tri-Service Gereral Hospital; 🇨🇳 Taipei, Taiwan