RecruitingNot ApplicableNCT06531083

Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus

Feasibility of PRospective Surveillance and Early PhysiCal Therapy for TrIsmuS in Individuals With Head and Neck CancEr: A Single-Group Feasibility Trial (PRECISE)


Sponsor

University of Alberta

Enrollment

30 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether regular monitoring and early physical therapy can prevent or reduce trismus (difficulty opening the mouth) in patients with head and neck cancer who are undergoing radiation therapy. Trismus is a common and debilitating side effect of radiation to the jaw and throat area. **You may be eligible if...** - You have been diagnosed with oral, oropharyngeal (throat), or nasopharyngeal (back of nose) cancer - You are scheduled to receive radiation therapy as part of your cancer treatment - You can read and understand English - You live in Alberta, Canada **You may NOT be eligible if...** - You have previously had surgery on the jaw joint (TMJ) unrelated to your cancer - Your cancer has come back or spread (recurrence or metastasis) - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALEarly physical therapy intervention

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


Locations(1)

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, Canada

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NCT06531083


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