Trismus exercise adherence during radiotherapy

Not Applicable

• Conditions: trismus; radiation therapy; Cancer - Head and neck

• Registration Number: ACTRN12623001324606
• Lead Sponsor: Chris O'Brien Lifehouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-18
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

1. Diagnosis of oral, oropharyngeal (base of tongue or tonsil) or nasopharyngeal cancer
2. Treatment involves radiotherapy in the definitive or adjuvant setting.
3. Willingness to provide informed consent and willingness to participate and comply with the study requirements
4. Able to complete questionnaires (with an interpreter/support person if necessary)
5. Adults, 18 years and over

Exclusion Criteria

1. Any participant who has non-union of the maxilla or mandible prior to commencing radiation (for example, if they had a jaw reconstruction which had not healed appropriately prior to radiation) or active osteoradionecrosis (ORN) (based on CT/X-RAY imaging after completing radiation). These conditions will be monitored by their treating surgeon at routine pre- and post-radiation review visits. Monitoring for non-union of the jaw after jaw surgery, and for signs of osteoradionecrosis after finishing radiation are routine practice/standard care. Signs include exposed bone, unmanaged pain or swelling, the managing radiation oncologist or surgeon would then recommend imaging within 1 week to investigate for non-union or ORN. If a patient is under investigation for non-union or ORN, they will be excluded from the trial.
2. Participants who have a pre-existing condition that is contraindicative of resistance-based jaw stretching exercises, for example arthritis of the temporomandibular joint, unstable dentition or any other joint degradation condition effecting the temporomandibular joint.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine whether the stretching regimen impacts adherence during radiotherapy and at 3, 6 and 12 months post radiotherapy[Intervention journal or REDCap will be filled out by patients. For those who wish to do so, a paper based journal will be provided Baseline at screening, enrolment visit, vist 1-6 during radiotherapy, 2 and 4 weeks, then 3, 6 and 12 months post radiotherapy]