Clinical trial NCT06531083: Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus
Official title: Feasibility of PRospective Surveillance and Early PhysiCal Therapy for TrIsmuS in Individuals With Head and Neck CancEr: A Single-Group Feasibility Trial (PRECISE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Trismus
Keywords: Physical Therapy
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Health services
First posted: 2024-07-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective surveillance with early intervention
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Feasibility: completion rate
timeFrame: 2 years
Secondary outcomes:
measure: Feasibility: recruitment rate
timeFrame: 2 years
measure: Feasibility: adherence rate
timeFrame: 6 weeks.
measure: Maximal interincisal opening
timeFrame: 3 months
measure: Trismus symptom questionnaire
timeFrame: 3 months
measure: Quality of life related to Head and Neck Cancer
timeFrame: 3 months
measure: Cervical range of motion
timeFrame: 3 months
measure: Neck Disability
timeFrame: 3 months
measure: Intervention effect on health status
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta/ Cross Cancer Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Margaret McNeely, PhD
role: PRINCIPAL_INVESTIGATOR
References: