Clinical Trial

Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus

Study acronym: PRECISE
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 changes
notable Primary completion pushed: 2026-06-30 -> 2026-09-30 2026-08-13
minor Completion pushed: 2026-08-31 -> 2026-09-30 2026-08-13
notable Primary completion pushed: 2026-01-31 -> 2026-06-30 2026-04-07
minor Completion pushed: 2026-05-31 -> 2026-08-31 2026-04-07
Trial Details
NCT Number NCT06531083
Lead Sponsor University of Alberta
Collaborators: Alberta Health services
Conditions Head and Neck Cancer, Trismus
Enrollment 30 participants
Start Date 2025-03-01
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-12