Clinical trial · Interventional
Physiotherapy for Radiation-induced Trismus
Prophylactic Physiotherapy Development Of Radiation-Induced Trismus In Patients With Head And Neck Cancer: Randomized Controlled Clinical Trial
NCT02094690CI-TRIAL-00036361completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to assess the effect of two protocols of physiotherapeutic exercises in the maintenance and/or increase of the mandibular range of movement in patients suffering from head and neck cancer (HNC) who are undergoing radiotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation-induced Fibrosis | — | UNRESOLVED | — |
| Trismus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperboloid | Device | — | UNRESOLVED |
| Therabite | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Device Hyperboloid
- description
- 5 min of bilateral mastication alternated with the device hyperboloid The exercises should begin one day before the onset of Radiotherapy (RT) and kept until the end of RT. Repeated 4x a day (after breakfast, lunch, dinner and before going to bed).
- interventionNames
- Device: Hyperboloid
- type
- ACTIVE_COMPARATOR
- label
- Device Therabite
- description
- * 10 repetitions holding the device Therabite for 30 seconds * 5 min of bilateral mastication alternated with the device hyperboloid The exercises should begin one day before the onset of Radiotherapy and kept until the end of RT. Repeated 4x a day (after breakfast, lunch, dinner and before going to bed).
- interventionNames
- Device: Therabite
- Device: Hyperboloid
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * signature of the Informed Consent Form; * both male and female individuals, aged 18 or over; * patients with a diagnosis of anatomopathological mouth and/or pharyngeal cancer; * patients who have undergone radiotherapy only, or radiotherapy combined with surgery and/or chemotherapy; * patients who have one or more muscles of mastication in the radiation field, and; * patients who have scored more than 60% in the Karnofsky Performance Status. Exclusion Criteria: * those with facial paralysis, trigeminal neuralgia and/or herpes zoster; * patients undergoing brachytherapy; * patients undergoing physiotherapy intervention.
References
Publications (0)
Data not yet available
No reference posted for this study.