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

Inclusion Criteria4

  • 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 Criteria3

  • 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.

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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