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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07139782
Registration number
NCT07139782
Ethics application status
Date submitted
17/08/2025
Date registered
24/08/2025
Date last updated
24/08/2025
Titles & IDs
Public title
Home-Based Photo-Biomodulation for Management of Lymphoedema and Radiation Fibrosis in Patients After Head and Neck Cancer: A Single-Arm Feasibility Trial
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Scientific title
Home-Based Photo-Biomodulation for Management of Lymphoedema and Radiation Fibrosis in Patients After Head and Neck Cancer: A Single-Arm Feasibility Trial
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Secondary ID [1]
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115976
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Universal Trial Number (UTN)
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Trial acronym
HOME-PBM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer
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Condition category
Condition code
Cancer
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Head and neck
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Riancorp LTU-904 Laser and Handycure® (Medical Quant)
Experimental: Intervention - RIANCORP
1. The therapist will complete 5 minutes of manual lymphatic drainage (MLD) prior to photo-biomodulation (PBM)
2. 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. The Riancorp has an in-built timer that signals the end of 60 seconds.
HANDYCURE PROTOCOL The Handycure device will be used at home by the patients, in addition to the usual care. Education, including written instruction sheets in how patients are to perform MLD, and use of the device will be provided.
The device is to be used once/day on the prescribed days (Wks 1-6 3x/wk; Wks 7-10 x2/wk; Wks 11-12 x1/wk)
1. Patients will complete 5 min of MLD prior to PBM
2. They will then apply the device for 5 minutes at each point.
Telehealth physio (wks 1, 6 and 9) post baseline will check usage, adherence and monitor safety.
Treatment: Devices: 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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Uptake (trial consent rate)
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Assessment method [1]
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Consent rate and reasons for declining trial participation
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Timepoint [1]
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Throughout the trial for 12-months of recruitment
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Secondary outcome [1]
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Adverse events
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Assessment method [1]
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Safety will be measured by the number of adverse events (AEs) related to the trial intervention and outcome assessments and reported according to the Common Terminology Criteria for Adverse Events version 5.
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Timepoint [1]
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Throughout the trial for 12-months of recruitment
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Secondary outcome [2]
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Acceptability
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Assessment method [2]
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Assessed by inviting a subgroup of patients (n=15-20) to complete an individual semi-structured interview by telephone or videoconferencing.
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Timepoint [2]
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Three months post baseline
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Secondary outcome [3]
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Program adherence
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Assessment method [3]
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The number of scheduled clinic and telehealth sessions attended
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Timepoint [3]
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Throughout the trial for 12-months of recruitment and completion of 3-month follow-up
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Secondary outcome [4]
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Program adherence
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Assessment method [4]
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Adherence to prescribed unsupervised intervention (PBM) sessions
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Timepoint [4]
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Throughout the trial for 12-months of recruitment and completion of 3-month follow-up
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Secondary outcome [5]
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Retention
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Assessment method [5]
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Patient retention at the follow-up assessment
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Timepoint [5]
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3-months post-baseline
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Secondary outcome [6]
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Neck circumference
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Assessment method [6]
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Neck circumference to be measured using the Assessment of Lymphoedema of the Head and Neck (ALOHA) method
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Timepoint [6]
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Baseline and 3-months post-baseline
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Secondary outcome [7]
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Lymphoedema
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Assessment method [7]
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The MD Anderson Cancer Centre Head and Neck Lymphoedema (MDACC HNL) Rating Scale will be used by the therapist to rate the degree of lymphoedema
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Timepoint [7]
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Baseline and 3-months post-baseline
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Secondary outcome [8]
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Percentage water content (PWC) of skin
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Assessment method [8]
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Percentage water content of the skin to be performed using the Lymph Scanner
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Timepoint [8]
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Baseline and 3-months post-baseline
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Secondary outcome [9]
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Cervical spine range of motion
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Assessment method [9]
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Neck range of motion to be measured with a digital goniometer
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Timepoint [9]
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Baseline and 3-months post-baseline
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Secondary outcome [10]
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Shoulder range of motion
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Assessment method [10]
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Shoulder range of movement to be measured with a digital goniometer
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Timepoint [10]
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Baseline and 3-months post-baseline
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Secondary outcome [11]
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Trismus
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Assessment method [11]
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Maximal incisal opening (trismus): The distance (in millimetres) between the edges of the maxillary and mandibular central incisors will be measured using the Therabite Range of Motion Scale.
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Timepoint [11]
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Baseline and 3-months post-baseline
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Secondary outcome [12]
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Health-related quality of life
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Assessment method [12]
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EORTC QLQ-HN43
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Timepoint [12]
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Baseline and 3-months post-baseline
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Eligibility
Key inclusion criteria
1. Patient has provided written informed consent using the HOME-PBM patient information and consent form
2. Patient is referred to the Lymphoedema Clinic for the management of head and neck lymphoedema and/or radiation fibrosis
3. Previously received curative-intent treatment (surgery and/or [chemo]radiotherapy) for mucosal head and neck cancer
4. Patient is able to attend appointments in person
5. Adults aged 18 years or older at Screening
6. Patient able to speak and read English
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. 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)
2. Residual or recurrent disease within the head and neck
3. Has a diagnosis of photosensitive disorder (cutaneous porphyria, xeroderma pigmentosum, etc.)
4. Patient has tuberculosis or another form of virulent bacteria
5. Patient has a contraindication to receiving PBM treatment
6. Patient has no internet enabled device for telehealth video follow-up appointment
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Study design
Purpose of the study
Other
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
4/09/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/10/2026
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Peter MacCallum Cancer Centre, Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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 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.
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Trial website
https://clinicaltrials.gov/study/NCT07139782
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Megan Howard
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Address
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Country
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Phone
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61 3 8559 5000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07139782
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