Recruiting

Early Intervention

Sponsor:

University of Alberta

Code:

NCT06531083

Conditions

Head and Neck Cancer

Trismus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Early physical therapy intervention

Study Details

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.

Conditions

Head and Neck Cancer

Trismus

Study ID

NCT06531083

Start date

Mar 1, 2025

Status verified date

Aug, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Early physical therapy intervention

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

Primary outcome measure

  • Feasibility: completion rate [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

University of Alberta/ Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 2G4

Contacts

Principal Investigator:

Margaret L. McNeely, PhD

More Information

Sponsor

University of Alberta

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • Physical Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-08-12.