Status:
NOT_YET_RECRUITING
Home-Based Photo-Biomodulation for Management of Lymphoedema and Radiation Fibrosis in Patients After Head and Neck Cancer: A Single-Arm Feasibility Trial
Lead Sponsor:
Peter MacCallum Cancer Centre, Australia
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- Patient has provided written informed consent using the HOME-PBM patient information and consent form
- Patient is referred to the Lymphoedema Clinic for the management of head and neck lymphoedema and/or radiation fibrosis
- Previously received curative-intent treatment (surgery and/or \[chemo\]radiotherapy) for mucosal head and neck cancer
- Patient is able to attend appointments in person
- Adults aged 18 years or older at Screening
- Patient able to speak and read English
Exclusion
- Patient has cognitive impairment that in the opinion of the Investigator would interfere with their ability to participate in the trial (e.g., complete outcome measures, perform the intervention)
- Residual or recurrent disease within the head and neck
- Has a diagnosis of photosensitive disorder (cutaneous porphyria, xeroderma pigmentosum, etc.)
- Patient has tuberculosis or another form of virulent bacteria
- Patient has a contraindication to receiving PBM treatment
- Patient has no internet enabled device for telehealth video follow-up appointment
Key Trial Info
Start Date :
September 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07139782
Start Date
September 4 2025
End Date
October 31 2026
Last Update
August 24 2025
Active Locations (1)
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1
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000