Exercise Therapy and Jaw-Mobilizing Device for Trismus in Head and Neck Cancer Patients (ET-JMD for Tri)

Exercise Therapy Combined with a Jaw-Mobilizing Device for Improving Maximal Mouth Opening and Trismus in Patients with Head and Neck Cancer: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Trismus; Head and Neck Cancers; Radiotherapy Side Effects
• Intervention / Treatment: Behavioral: combination of exercise therapy and a jaw-mobilizing device; Behavioral: exercise therapy only

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • tri-Service Gereral Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Participants in the experimental group will receive a combination of exercise therapy and a jaw-mobilizing device. The intervention includes structured exercise therapy sessions and the use of the jaw-mobilizing device for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes.	Behavioral: combination of exercise therapy and a jaw-mobilizing device; Participants in the experimental group will receive a combination of exercise therapy and a jaw-mobilizing device. The intervention includes structured exercise therapy sessions and the use of the jaw-mobilizing device for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes.
Placebo Comparator: Control Group; Participants in the control group will receive exercise therapy only. This intervention involves the same structured exercise therapy sessions as the experimental group for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes.	Behavioral: exercise therapy only; Participants in the control group will receive exercise therapy only. This intervention involves the same structured exercise therapy sessions as the experimental group for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal Mouth Opening	Change in Maximal Mouth Opening (MMO) from Baseline to Week 36. higher score means worse.	Baseline to Week 36

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Trismus; Radiotherapy-Induced Mouth Opening Limitation
• 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: Jaw-Mobilizing Device

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

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