Feasibility of PRospective Surveillance and Early PhysiCal Therapy for TrIsmuS in Individuals With Head and Neck CancEr: A Single-Group Feasibility Trial (PRECISE)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Alberta
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Feasibility: completion rate
Study Overview
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
- 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Early physical therapy intervention (Behavioral)
Outcomes
Primary Outcomes
Feasibility: completion rate
Time Frame: 2 years
Number of participants completing the study.
Secondary Outcomes
- Maximal interincisal opening(3 months)
- Intervention effect on health status(6 weeks)
- Feasibility: recruitment rate(2 years)
- Feasibility: adherence rate(6 weeks.)
- Quality of life related to Head and Neck Cancer(3 months)
- Cervical range of motion(3 months)
- Neck Disability(3 months)
- Trismus symptom questionnaire(3 months)