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NCT Number: NCT06719388

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

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.

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Key information

Conditions

Head and Neck Cancers Head and Neck Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Radiotherapy Side Effects Signs and Symptoms Spasm Trismus

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

tri-Service Gereral Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Maximal Mouth Opening

    Time frame: Baseline to Week 36

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

Secondary outcomes

  1. Quality of Life Scores

    Time frame: Baseline to Week 36

    Change in Quality of Life Scores (EORTC QLQ-H&N35) from Baseline to Week 36. higher score means good quality.

  2. Trismus-Related Symptom Distress Scores

    Time frame: Baseline to Week 36

    Change in Trismus-Related Symptom Distress Scores (GTQ2) from Baseline to Week 36. higher score means worse.

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

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

Acronym: ET-JMD for Tri

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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