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

Taipei Medical University

Status: Completed

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

Treatments: Behavioral: combination of exercise therapy and a jaw-mobilizing device; Behavioral: exercise therapy only

Study type: Interventional

Funder types: Other

Identifiers

NCT06719388

Jaw-Mobilizing Device

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

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.

Treatment:

Behavioral: combination of exercise therapy and a jaw-mobilizing device

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: exercise therapy only