Clinical trial · Interventional
Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus
Feasibility of PRospective Surveillance and Early PhysiCal Therapy for TrIsmuS in Individuals With Head and Neck CancEr: A Single-Group Feasibility Trial (PRECISE)
- 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, or restricted jaw movement, can occur in individuals with head and neck cancer (HNC) undergoing surgery or radiation therapy. There is a paucity of research examining interventions for trismus. We aim to assess the feasibility of prospective surveillance and early intervention to mitigate trismus in individuals undergoing HNC treatment. Method: The investigators will conduct a pilot single group feasibility study involving 30 individuals with HNC who will be undergoing radiation therapy. Participants will be identified at the HNC new patient clinic. Participants will be seen weekly during radiation therapy and will receive early intervention including manual therapy and a device-based jaw exercise regimen if presenting with 5% or greater reduction in jaw opening compared to pre-treatment. The investigators will assess recruitment and completion rates, intervention acceptability, and data collection procedures. Descriptive statistics will summarize feasibility metrics and participant demographics. Findings will inform the design of a larger multicentre trial.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Trismus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early physical therapy intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prospective Surveillance for Trismus and Early Physical Therapy Intervention
- description
- Weekly monitoring of mouth opening and jaw function. Early intervention if the participant presents with 5% or greater reduction in mouth opening compared to pre-treatment measures. Early intervention will comprise: physical therapy, home exercises and use of a jaw stretching device.
- interventionNames
- Behavioral: Early physical therapy intervention
Primary outcomes (1)
- measure
- Feasibility: completion rate
- timeFrame
- 2 years
- description
- Number of participants completing the study.
Secondary outcomes (8)
- measure
- Feasibility: recruitment rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have a diagnosis of oral, oropharyngeal, or nasopharyngeal cancer * Be scheduled to undergo cancer treatment that includes radiation therapy * Be able to read and understand English * Be an Alberta resident. Exclusion Criteria: * Previous surgery for the temporomandibular joint that is not related to the HNC diagnosis. * Local cancer recurrence or metastatic disease. * Unable to provide informed consent.
References
Publications (0)
Data not yet available