Clinical trial · Interventional
Prevention of Trismus During Radiotherapy and Quality of Life in Head and Neck Cancer Patients
Prophylactic Training for the Prevention of Radiotherapy-induced Trismus - a Randomised Study. Health-related Quality of Life up to One Year After Radiotherapy in Patients With Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Trismus (limited jaw mobility), can occur in patients undergoing radiotherapy to specific areas of the head or neck. Trismus leads to difficulty in eating, swallowing, speech and general mouth hygiene, which all have negative effects on quality of life. Research in the area of trismus is limited; it is not known exactly when trismus develops, one study suggests that some patients have experienced a diminished opening at as low doses as 15 Gy. Literature suggests benefits of a training programme, but there is a lack of evidence to support the use of a training programme during radiotherapy. The purpose of this study is to investigate the effectiveness of a training programme during and after radiotherapy, and report the incidence of trismus in patients who receive radiotherapy to the jaw muscles. The study also investigates quality of life during radiotherapy and up to one year after completed treatment. Patients who meet the criteria and give their consensus to the study are divided into two groups: Group 1: Training with TheraBite Jaw Motion Rehabilitation System, which is a portable system utilizing repetitive passive motion and stretching to restore mobility and flexibility of the jaw musculature. Individuals train five times a day. Group 2: Conventional treatment (jaw measurements once a week). If the individuals jaw mobility decreases 15% from the original start measurement, the patient is automatically offered a trainings program (as in group 1). During radiation therapy a hospital specialist dentist measures the jaw mobility once a week, thereafter at 3,6,12 months after completed Radiation Therapy. On 5 different occasions the patients are requested to complete a Quality of life questionnaire. Patient's record their training frequency in a log book.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Trismus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TheraBite® Jaw Motion Rehabilitation System™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TheraBite grupp
- interventionNames
- Device: TheraBite® Jaw Motion Rehabilitation System™
- type
- NO_INTERVENTION
- label
- Conventional treatment
Primary outcomes (1)
- measure
- Change in Jaw mobility measurement during Radiotherapy
- timeFrame
- Up to 7 weeks
- description
- Proportion of participants free from trismus at the end of Radiotherapy.
Secondary outcomes (1)
- measure
- Change in Jaw Mobility measurement at 6 and 12 months after completed Radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 or older * Be able to communicate and understand the Swedish language. * Compliance with training programme and follow-up during the study time period. * Planed radiotherapy dose of at least 15Gy to the jaw muscles. * Tooth 11 and 41 intact. Exclusion Criteria: * An operation in the target area that has already affected jaw mobility. * Jaw measurement under 35mm.
References
Publications (0)
Data not yet available