Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus

NCT ID: NCT06531083

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-05-31

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.

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 will be a single group study involving 30 individuals with HNC who are undergoing radiation therapy +/- chemotherapy (with or without prior surgery). 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.

Conditions

Head and Neck Cancer; Trismus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Early physical therapy intervention

Intervention Type: BEHAVIORAL

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

Interventions

Early physical therapy intervention

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alberta Health services

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret McNeely, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Margaret McNeely, PhD

Role: CONTACT

mmcneely@ualberta.ca

780-492-6007

Lynn Mohamad, PhDc

Role: CONTACT

frmace@ualberta.ca

780-492-6007

Facility Contacts

Margaret McNeely, PhD

Role: primary

mmcneely@ualberta.ca

780-248-1531

Other Identifiers

HREBA.CC-24-0240

Identifier Type: -

Identifier Source: org_study_id