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

NCT06719388 | Completed DMC

• 1 other identifier: Jaw-Mobilizing Device
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancers; Trismus; Radiotherapy Side Effects

Keywords

Head and Neck Cancer; Trismus; Radiotherapy-Induced Mouth Opening Limitation

Outcome Measures

Primary Outcomes (1)

• Maximal Mouth Opening

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

  Baseline to Week 36

Secondary Outcomes (2)

• Quality of Life Scores

  Baseline to Week 36

• Trismus-Related Symptom Distress Scores

  Baseline to Week 36

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Interventions

combination of exercise therapy and a jaw-mobilizing device BEHAVIORAL

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.

Experimental Group

exercise therapy only BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

tri-Service Gereral Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Trismus

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are unaware of their group allocation (experimental or control) to minimize bias in self-reported outcomes and adherence to the intervention. However, investigators and outcome assessors are not masked due to the nature of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are randomly assigned to one of two parallel groups: the experimental group, which receives exercise therapy combined with a jaw-mobilizing device, or the control group, which receives exercise therapy only. Both groups are followed concurrently throughout the study period.

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 5, 2024
• Study Start: December 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: October 31, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TW (1)