Home-Based Photo-Biomodulation for Management of Lymphoedema and Radiation Fibrosis in Patients A… (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
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Uptake (trial consent rate)
Timeframe: Throughout the trial for 12-months of recruitment