Head and Neck CancerPRECISENCT06531083
Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus
A study testing Early physical therapy intervention in people with Head and Neck Cancer and Trismus, run by University of Alberta at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Trismus
- What is being tested?
- Early physical therapy intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, T6G 2G4
Margaret McNeely, PhD, 780-248-1531, mmcneely@ualberta.ca
Margaret L. McNeely, PhD
About this study
Official title: Feasibility of PRospective Surveillance and Early PhysiCal Therapy for TrIsmuS in Individuals With Head and Neck CancEr: A Single-Group Feasibility Trial (PRECISE)
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.
Read the detailed description
- Background and rationale : Head and neck cancers (HNCs) originate in the nasal cavity, sinuses, lips, mouth, salivary glands, throat, and larynx. Individuals undergoing treatment for HNC often develop side effects such as oral mucositis xerostomia and experience difficulties with swallowing and speech. Along with these side effects, individuals with oral and oropharyngeal cancers can develop trismus, defined as restricted mouth opening (< 35mm).The beneficial effects of early physical therapy programs in mitigating the incidence of trismus have not yet been fully established, and there are no validated protocols or guidelines regarding exercise therapy. The findings of this study will be crucial in developing effective rehabilitation strategies for patients with HNC and also will contribute to the development of tailored exercise programs and rehabilitation protocols, enabling physical therapists specifically to deliver personalized care for individuals with HNC.
- Research question and Objectives : i. To evaluate the feasibility of a prospective surveillance approach for the early detection of trismus in patients with HNC. ii. To determine the acceptability of implementing an early physical therapy intervention which includes jaw and neck exercises, manual therapy for the jaw, and the use of a jaw device for managing trismus in individuals with HNC.
- Methodology : This feasibility two-phase study will recruit individuals with HNC, who are undergoing or have completed radiotherapy. Phase I includes two cohorts: (1) a prospective surveillance cohort of individuals undergoing radiotherapy who are at risk of developing trismus, and (2) a post-radiotherapy cohort of individuals with established trismus. In the surveillance cohort, PT will be initiated if jaw mobility declines by >5% relative to pre-treatment baseline or reaches a threshold of ≤35 mm. Participants in the post-radiotherapy cohort with established trismus (Mouth Opening (MO) ≤35 mm) will receive PT at enrolment. The intervention will include MT and therapeutic exercise. 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. Participants will be identified at the HNC new patient clinic. Participants 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.
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.
- Conditions
- Head and Neck Cancer, Trismus
- Being tested
- Early physical therapy intervention
- Keywords
- Physical Therapy
- Medical subject headings
- Head and Neck Neoplasms, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early physical therapy interventionBehavioural
Physical therapy including manual therapy, home exercises for the neck and jaw, and use of a jaw stretching device.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Surveillance for Trismus and Early Physical Therapy Intervention | Experimental | 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. Receives: Behavioral: Early physical therapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: completion rate
Number of participants completing the study.
Measured: 2 years
Secondary outcomes (8)
Feasibility: recruitment rate
Number of participants entering the study by the number of participants eligible.
Measured: 2 years
Feasibility: adherence rate
Percentage of sessions completed over the 6-week intervention period.
Measured: 6 weeks.
Maximal interincisal opening
The distance from the incisal border of tooth #21 to the middle of incisal border of tooth #31
Measured: 3 months
Trismus symptom questionnaire
Revised Gothenburg Trismus Questionnaire (0-100): higher scores indicate higher symptom burden
Measured: 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.
Measured: 3 months
Cervical range of motion
Quantification of neck range of motion: higher scores reflect better function
Measured: 3 months
Neck Disability
Neck Disability Index (0-50): higher scores reflect more disability
Measured: 3 months
Intervention effect on health status
Global rating of change scale (VAS -7 to +7)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Mar 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective surveillance with early intervention
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Margaret McNeely, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531083
- Sponsor's protocol ID
- HREBA.CC-24-0240
- Acronym
- PRECISE
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on Borealis (University of Alberta)
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of PRospective Surveillance and Early PhysiCal Therapy for TrIsmuS in Individuals With Head and Neck CancEr: A Single-Group Feasibility Trial (PRECISE)
- ClinicalTrials.gov ID
- NCT06531083
- Acronym / sponsor ID
- PRECISE / HREBA.CC-24-0240
- Conditions
- Head and Neck Cancer, Trismus
- Keywords
- Physical Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Background and rationale : Head and neck cancers (HNCs) originate in the nasal cavity, sinuses, lips, mouth, salivary glands, throat, and larynx. Individuals undergoing treatment for HNC often develop side effects such as oral mucositis xerostomia and experience difficulties with swallowing and speech. Along with these side effects, individuals with oral and oropharyngeal cancers can develop trismus, defined as restricted mouth opening (< 35mm).The beneficial effects of early physical therapy programs in mitigating the incidence of trismus have not yet been fully established, and there are no validated protocols or guidelines regarding exercise therapy. The findings of this study will be crucial in developing effective rehabilitation strategies for patients with HNC and also will contribute to the development of tailored exercise programs and rehabilitation protocols, enabling physical therapists specifically to deliver personalized care for individuals with HNC.
- Research question and Objectives : i. To evaluate the feasibility of a prospective surveillance approach for the early detection of trismus in patients with HNC. ii. To determine the acceptability of implementing an early physical therapy intervention which includes jaw and neck exercises, manual therapy for the jaw, and the use of a jaw device for managing trismus in individuals with HNC.
- Methodology : This feasibility two-phase study will recruit individuals with HNC, who are undergoing or have completed radiotherapy. Phase I includes two cohorts: (1) a prospective surveillance cohort of individuals undergoing radiotherapy who are at risk of developing trismus, and (2) a post-radiotherapy cohort of individuals with established trismus. In the surveillance cohort, PT will be initiated if jaw mobility declines by >5% relative to pre-treatment baseline or reaches a threshold of ≤35 mm. Participants in the post-radiotherapy cohort with established trismus (Mouth Opening (MO) ≤35 mm) will receive PT at enrolment. The intervention will include MT and therapeutic exercise. 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. Participants will be identified at the HNC new patient clinic. Participants 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective surveillance with early intervention
| Arm | Type | Receives |
|---|---|---|
| Prospective Surveillance for Trismus and Early Physical Therapy Intervention | Experimental | Behavioral: Early physical therapy interventionWeekly 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early physical therapy interventionPhysical therapy including manual therapy, home exercises for the neck and jaw, and use of a jaw stretching device. | Behavioural | Prospective Surveillance for Trismus and Early Physical Therapy Intervention |
Primary outcome
Feasibility: completion rate
Time frame: 2 years
Number of participants completing the study.
8 secondary outcomes
Feasibility: recruitment rate
Time frame: 2 years
Feasibility: adherence rate
Time frame: 6 weeks.
Maximal interincisal opening
Time frame: 3 months
Trismus symptom questionnaire
Time frame: 3 months
Quality of life related to Head and Neck Cancer
Time frame: 3 months
Cervical range of motion
Time frame: 3 months
Neck Disability
Time frame: 3 months
Intervention effect on health status
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. Data will be available on Borealis (University of Alberta)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margaret McNeely, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early physical therapy intervention in people with Head and Neck Cancer and Trismus, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margaret McNeely, PhD (780-492-6007, mmcneely@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: completion rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.