Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus

NCT06531083 | Recruiting

• 1 other identifier: HREBA.CC-24-0240
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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

Head and Neck Cancer; Trismus

Keywords

Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Feasibility: completion rate

  Number of participants completing the study.

  2 years

Secondary Outcomes (8)

• Feasibility: recruitment rate

  2 years

• Feasibility: adherence rate

  6 weeks.

• Maximal interincisal opening

  3 months

• Trismus symptom questionnaire

  3 months

• Quality of life related to Head and Neck Cancer

  3 months

Study Arms (1)

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.

Behavioral: Early physical therapy intervention

Interventions

Early physical therapy intervention BEHAVIORAL

Physical therapy including manual therapy, home exercises for the neck and jaw, and use of a jaw stretching device.

Prospective Surveillance for Trismus and Early Physical Therapy Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator

Study Sites (1)

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, T6G 2G4, Canada

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Trismus

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Margaret McNeely, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret McNeely, PhD

CONTACT

780-492-6007; mmcneely@ualberta.ca

Lynn Mohamad, PhDc

CONTACT

780-492-6007; frmace@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective surveillance with early intervention

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 31, 2024
• Study Start: March 1, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be made available following publication of the primary paper.
• Access Criteria: On request from research team

Locations

CA (1)