About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Early physical therapy intervention
BehavioralPhysical therapy including manual therapy, home exercises for the neck and jaw, and use of a jaw stretching device.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility: completion rate
Number of participants completing the study.
Secondary outcomes
Feasibility: recruitment rate
Number of participants entering the study by the number of participants eligible.
Feasibility: adherence rate
Percentage of sessions completed over the 6-week intervention period.
Maximal interincisal opening
The distance from the incisal border of tooth #21 to the middle of incisal border of tooth #31
Trismus symptom questionnaire
Revised Gothenburg Trismus Questionnaire (0-100): higher scores indicate higher symptom burden
Sponsors and contacts
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University of Alberta
Lead sponsor
Alberta Health services
Collaborator