Head and Neck CancerHOME-PBMNCT07139782
Home-Based Photo-Biomodulation for Management of Lymphoedema and Radiation Fibrosis in Patients After Head and Neck Cancer: A Single-Arm Feasibility Trial
A study testing Riancorp LTU-904 Laser and Handycure® (Medical Quant) in people with Head and Neck Cancer, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Riancorp LTU-904 Laser and Handycure® (Medical Quant)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Sep 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Megan Howard, 61 3 8559 5000, megan.howard@petermac.org
Lara Edbrooke, B App Sc (Physio), GDEB, PhD, 8559 5234, lara.edbrooke@petermac.org
About this study
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.
- Conditions
- Head and Neck Cancer
- Being tested
- Riancorp LTU-904 Laser and Handycure® (Medical Quant)
- Keywords
- head and neck cancer, photo-biomodulation, radiation fibrosis, lymphoedema, physiotherapy
- Medical subject headings
- Head and Neck Neoplasms, Radiation Fibrosis Syndrome, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riancorp LTU-904 Laser and Handycure® (Medical Quant)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Device: Riancorp LTU-904 Laser and Handycure® (Medical Quant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake (trial consent rate)
Consent rate and reasons for declining trial participation
Measured: Throughout the trial for 12-months of recruitment
Secondary outcomes (12)
Adverse events
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.
Measured: Throughout the trial for 12-months of recruitment
Acceptability
Assessed by inviting a subgroup of patients (n=15-20) to complete an individual semi-structured interview by telephone or videoconferencing.
Measured: Three months post baseline
Program adherence
The number of scheduled clinic and telehealth sessions attended
Measured: Throughout the trial for 12-months of recruitment and completion of 3-month follow-up
Program adherence
Adherence to prescribed unsupervised intervention (PBM) sessions
Measured: Throughout the trial for 12-months of recruitment and completion of 3-month follow-up
Retention
Patient retention at the follow-up assessment
Measured: 3-months post-baseline
Neck circumference
Neck circumference to be measured using the Assessment of Lymphoedema of the Head and Neck (ALOHA) method
Measured: Baseline and 3-months post-baseline
Lymphoedema
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
Measured: Baseline and 3-months post-baseline
Percentage water content (PWC) of skin
Percentage water content of the skin to be performed using the Lymph Scanner
Measured: Baseline and 3-months post-baseline
Cervical spine range of motion
Neck range of motion to be measured with a digital goniometer
Measured: Baseline and 3-months post-baseline
Shoulder range of motion
Shoulder range of movement to be measured with a digital goniometer
Measured: Baseline and 3-months post-baseline
Trismus
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.
Measured: Baseline and 3-months post-baseline
Health-related quality of life
EORTC QLQ-HN43
Measured: Baseline and 3-months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start4 Sep 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139782
- Sponsor's protocol ID
- 115976
- Acronym
- HOME-PBM
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Photo-Biomodulation for Management of Lymphoedema and Radiation Fibrosis in Patients After Head and Neck Cancer: A Single-Arm Feasibility Trial
- ClinicalTrials.gov ID
- NCT07139782
- Acronym / sponsor ID
- HOME-PBM / 115976
- Conditions
- Head and Neck Cancer
- Keywords
- head and neck cancer, photo-biomodulation, radiation fibrosis, lymphoedema, physiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Study start
- 4 Sep 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Riancorp LTU-904 Laser and Handycure® (Medical Quant)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Intervention |
Primary outcome
Uptake (trial consent rate)
Time frame: Throughout the trial for 12-months of recruitment
Consent rate and reasons for declining trial participation
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Riancorp LTU-904 Laser and Handycure® (Medical Quant) in people with Head and Neck Cancer, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Howard (61 3 8559 5000, megan.howard@petermac.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake (trial consent rate) (time frame: Throughout the trial for 12-months of recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.