Home-Based Photo-Biomodulation for Management of Lymphoedema and Radiation Fibrosis in Patients After Head and Neck Cancer: A Single-Arm Feasibility Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Riancorp LTU-904 Laser and Handycure® (Medical Quant).
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Riancorp LTU-904 Laser and Handycure® (Medical Quant)
Riancorp: At the first intervention session the therapist will apply the device for 60 secs each at 14 - 25 points on the face and neck. Most patients will need application of the device at 15 to 20 points The Riancorp runs for 60 seconds, providing 1.5 j/cm2 in 60 seconds. Handycure: used by patients at home once/day on the prescribed days (Wks 1-6 3x/wk; Wks 7-10 x2/wk; Wks 11-12 x1/wk) 1. Patients will apply the device for 5 minutes at each point as instructed by the physiotherapist.
Primary outcome measures
- Uptake (trial consent rate) [Time frame: Throughout the trial for 12-months of recruitment]
Secondary outcome measures (12)
- Adverse events [Time frame: Throughout the trial for 12-months of recruitment]
- Acceptability [Time frame: Three months post baseline]
- Program adherence [Time frame: Throughout the trial for 12-months of recruitment and completion of 3-month follow-up]
- Program adherence [Time frame: Throughout the trial for 12-months of recruitment and completion of 3-month follow-up]
- Retention [Time frame: 3-months post-baseline]
- Neck circumference [Time frame: Baseline and 3-months post-baseline]
- Lymphoedema [Time frame: Baseline and 3-months post-baseline]
- Percentage water content (PWC) of skin [Time frame: Baseline and 3-months post-baseline]
- Cervical spine range of motion [Time frame: Baseline and 3-months post-baseline]
- Shoulder range of motion [Time frame: Baseline and 3-months post-baseline]
- Trismus [Time frame: Baseline and 3-months post-baseline]
- Health-related quality of life [Time frame: Baseline and 3-months post-baseline]
Eligibility criteria
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)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Australia · 1 center
- Peter MacCallum Cancer Centre — Melbourne
Identifiers
NCT: NCT07139782 · 115976