Home-Based Photo-Biomodulation for Management of Lymphoedema and Radiation Fibrosis in Patients Aā¦ (NCT07139782) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Home-Based Photo-Biomodulation for Management of Lymphoedema and Radiation Fibrosis in Patients After Head and Neck Cancer: A Single-Arm Feasibility Trial
Australia30 participantsStarted 2025-09-04
Plain-language 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.
Who can participate
SexALL
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Inclusion criteria
ā. Patient has provided written informed consent using the HOME-PBM patient information and consent form
ā. Patient is referred to the Lymphoedema Clinic for the management of head and neck lymphoedema and/or radiation fibrosis
ā. Previously received curative-intent treatment (surgery and/or \[chemo\]radiotherapy) for mucosal head and neck cancer
ā. Patient is able to attend appointments in person
ā. Adults aged 18 years or older at Screening
ā. Patient able to speak and read English
Exclusion criteria
ā. 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)
ā. Residual or recurrent disease within the head and neck
ā. Has a diagnosis of photosensitive disorder (cutaneous porphyria, xeroderma pigmentosum, etc.)
ā. Patient has tuberculosis or another form of virulent bacteria
What they're measuring
1
Uptake (trial consent rate)
Timeframe: Throughout the trial for 12-months of recruitment