An interventional study of combination of exercise therapy and a jaw-mobilizing device and exercise therapy only in Head and Neck Cancers, Trismus and Radiotherapy Side Effects, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Supportive care
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.
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's enrollment of 34 is below the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Taipei Medical University is the lead sponsor of 257 studies on the registry; 59 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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.
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.
Maximal Mouth Opening
Change in Maximal Mouth Opening (MMO) from Baseline to Week 36. higher score means worse.
Time frame: Baseline to Week 36
Quality of Life Scores
Change in Quality of Life Scores (EORTC QLQ-H\&N35) from Baseline to Week 36. higher score means good quality.
Time frame: 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.
Time frame: Baseline to Week 36
Plan to share: Yes
Supporting information: Study protocol
No publications or documents are linked to this record.
Ran from Dec 2021 to primary completion in Jun 2023, 18 months.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's 18 months is below that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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