Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus (PRECISE)

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Trismus
• Intervention / Treatment: Behavioral: Early physical therapy intervention

Detailed Description

1. 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.
2. 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.
3. 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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margaret McNeely, PhD; Phone Number: 780-492-6007; Email: mmcneely@ualberta.ca
• Study Contact Backup: Name: Lynn Mohamad, PhDc; Phone Number: 780-492-6007; Email: frmace@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2G4
      • Recruiting
      • University of Alberta/ Cross Cancer Institute
      • Principal Investigator: Margaret L. McNeely, PhD
      • Contact: Margaret McNeely, PhD; Phone Number: 780-248-1531; Email: mmcneely@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prospective Surveillance for Trismus and Early Physical Therapy Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: completion rate	Number of participants completing the study.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: recruitment rate	Number of participants entering the study by the number of participants eligible.	2 years
Feasibility: adherence rate	Percentage of sessions completed over the 6-week intervention period.	6 weeks.
Maximal interincisal opening	The distance from the incisal border of tooth #21 to the middle of incisal border of tooth #31	3 months
Trismus symptom questionnaire	Revised Gothenburg Trismus Questionnaire (0-100): higher scores indicate higher symptom burden	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.	3 months
Cervical range of motion	Quantification of neck range of motion: higher scores reflect better function	3 months
Neck Disability	Neck Disability Index (0-50): higher scores reflect more disability	3 months
Intervention effect on health status	Global rating of change scale (VAS -7 to +7)	6 weeks

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Alberta Health services
• Investigators: Principal Investigator: Margaret McNeely, PhD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 27, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Physical Therapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Neoplasms by Site; Neoplasms; Spasm; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Head and Neck Neoplasms; Trismus
• Other Study ID Numbers: HREBA.CC-24-0240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available on Borealis (University of Alberta)
• IPD Sharing Time Frame: The data will be made available following publication of the primary paper.
• IPD Sharing Access Criteria: On request from research team
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No