Head and Neck Cancers, Radiotherapy Side Effects, Trismus
Conditions
Keywords
Head and Neck Cancer, Trismus, Radiotherapy-Induced Mouth Opening Limitation
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.
Interventions
BEHAVIORALcombination 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.
BEHAVIORALexercise 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.
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Mouth Opening | Baseline to Week 36 | Change in Maximal Mouth Opening (MMO) from Baseline to Week 36. higher score means worse. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan
Outcome results
None listed