An interventional study of Early physical therapy intervention in Head and Neck Cancer and Trismus, sponsored by University of Alberta. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by University of Alberta · Not applicable, Interventional, and Supportive care
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.
Phase II includes a qualitative assessment of the study's acceptability and delivery.
The primary outcome is feasibility, including recruitment, adherence, and completion rates. Changes in MO will be explored descriptively as a secondary outcome.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 30 is below the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Early physical therapy intervention
Physical therapy including manual therapy, home exercises for the neck and jaw, and use of a jaw stretching device.
Feasibility: completion rate
Number of participants completing the study.
Time frame: 2 years
Feasibility: recruitment rate
Number of participants entering the study by the number of participants eligible.
Time frame: 2 years
Feasibility: adherence rate
Percentage of sessions completed over the 6-week intervention period.
Time frame: 6 weeks.
Maximal interincisal opening
The distance from the incisal border of tooth #21 to the middle of incisal border of tooth #31
Time frame: 3 months
Trismus symptom questionnaire
Revised Gothenburg Trismus Questionnaire (0-100): higher scores indicate higher symptom burden
Time frame: 3 months
Quality of life related to Head and Neck Cancer
University of Washington Quality of Life scale (scored 0 to 100): higher scores indicate better functioning.
Time frame: 3 months
Cervical range of motion
Quantification of neck range of motion: higher scores reflect better function
Time frame: 3 months
Neck Disability
Neck Disability Index (0-50): higher scores reflect more disability
Time frame: 3 months
Intervention effect on health status
Global rating of change scale (VAS -7 to +7)
Time frame: 6 weeks
Plan to share: Yes — Data will be available on Borealis (University of Alberta)
Supporting information: Study protocol, Informed consent form
Time frame: The data will be made available following publication of the primary paper.
Access criteria: On request from research team
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Sep 2026, 18 months after the start.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 18 months is below that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
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