Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus

Trial Title: Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus

NCT ID: NCT06531083

Condition: Head and Neck Cancer
Trismus

Conditions: Official terms:
Head and Neck Neoplasms
Trismus

Conditions: Keywords:
Physical Therapy

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Randomized controlled feasibility trial

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Masking description: Independent assessors will be blinded to group assignment.

Intervention:

Intervention type: Behavioral
Intervention name: Supportive Care
Description: Active and passive exercises for the neck and jaw.
Arm group label: Prospective Surveillance for Trismus and Early Physical Therapy Intervention
Arm group label: Usual Care

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 randomized feasibility trial involving 30 individuals with HNC who will be undergoing radiation therapy. Participants will be identified at the HNC new patient clinic. Those consenting will be randomized to either usual care (UC) or to prospective surveillance (PS). UC participants will receive active exercises, and referral to physical therapy if trismus is detected. Participants in the PS group 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. iii. To explore the preliminary effectiveness of the intervention when compared with standard care on relevant outcomes, such as mouth opening, jaw and neck function, and quality of life. 3. Methodology : This will be a pilot randomized feasibility trial 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. Those consenting will be randomized to either usual care (UC) or to prospective surveillance (PS). UC participants will receive active exercises, and referral to physical therapy if trismus is detected. Participants in the PS group 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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Alberta/ Cross Cancer Institute

Address:
City: Edmonton
Zip: T6G 2G4
Country: Canada

Start date: November 2, 2024

Completion date: May 31, 2026

Lead sponsor:
Agency: University of Alberta
Agency class: Other

Collaborator:
Agency: Alberta Health services
Agency class: Other

Source: University of Alberta

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06531083