Clinical Trial

Home-Based Photo-Biomodulation for Management of Lymphoedema and Radiation Fibrosis in Patients After Head and Neck Cancer: A Single-Arm Feasibility Trial

Study acronym: HOME-PBM
Not Yet Recruiting
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Record status
This record was last updated August 24, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
This feasibility trial will test the use of photo-biomodulation (PBM) therapy, predominantly self-delivered in the patient's home for 12-weeks, following completion of radiotherapy treatment for head and neck cancer. The primary objective is to establish feasibility of recruitment (uptake). Secondary objectives are to assess safety, additional elements of feasibility (adherence to the intervention, return of the device and attrition at the 3-month follow-up appointment) and acceptability of the trial to patients. Secondary measures will be performed to assess trends in effects of the intervention (pre-post intervention, within-group measures) for managing lymphoedema and radiation fibrosis.
Trial Details
NCT Number NCT07139782
Lead Sponsor Peter MacCallum Cancer Centre, Australia
Conditions Head and Neck Cancer
Enrollment 30 participants
Start Date 2025-09-04
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-10-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-24