Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus
- Conditions
- Head and Neck CancerTrismus
- Interventions
- Behavioral: Supportive Care
- Registration Number
- NCT06531083
- Lead Sponsor
- University of Alberta
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prospective Surveillance for Trismus and Early Physical Therapy Intervention Supportive Care 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. Usual Care Supportive Care Home exercise instruction and referral to physical therapy if trismus develops.
- Primary Outcome Measures
Name Time Method Feasibility: completion rate 2 years Number of participants completing the study.
- Secondary Outcome Measures
Name Time Method Feasibility: recruitment rate 2 years Number of participants entering the study by the number of participants eligible.
Feasibility: adherence rate 6 weeks. Percentage of sessions completed over the 6-week intervention period.
Quality of life related to Head and Neck Cancer 3 months University of Washington Quality of Life scale (scored 0 to 100): higher scores indicate better functioning.
Cervical range of motion 3 months Quantification of neck range of motion: higher scores reflect better function
Neck Disability 3 months Neck Disability Index (0-50): higher scores reflect more disability
Trismus symptom questionnaire 3 months Revised Gothenburg Trismus Questionnaire (0-100): higher scores indicate higher symptom burden
Maximal interincisal opening 3 months The distance from the incisal border of tooth #21 to the middle of incisal border of tooth #31
Intervention effect on health status 6 weeks Global rating of change scale (VAS -7 to +7)
Trial Locations
- Locations (1)
University of Alberta/ Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada