Home-Based Photo-Biomodulation for Management of Lymphoedema and Radiation Fibrosis in Patients After Head and Neck Cancer: A Single-Arm Feasibility Trial

NCT07139782 | Not Yet Recruiting

• 1 other identifier: 115976
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; photo-biomodulation; radiation fibrosis; lymphoedema; physiotherapy

Outcome Measures

Primary Outcomes (1)

• Uptake (trial consent rate)

  Consent rate and reasons for declining trial participation

  Throughout the trial for 12-months of recruitment

Secondary Outcomes (12)

• Adverse events

  Throughout the trial for 12-months of recruitment

• Acceptability

  Three months post baseline

• Program adherence

  Throughout the trial for 12-months of recruitment and completion of 3-month follow-up

• Program adherence

  Throughout the trial for 12-months of recruitment and completion of 3-month follow-up

• Retention

  3-months post-baseline

Study Arms (1)

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.

Device: Riancorp LTU-904 Laser and Handycure® (Medical Quant)

Interventions

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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Radiation Fibrosis Syndrome; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Radiation Injuries; Wounds and Injuries; Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Megan Howard

CONTACT

61 3 8559 5000; megan.howard@petermac.org

Lara Edbrooke, B App Sc (Physio), GDEB, PhD

CONTACT

61 3 8559 5234; lara.edbrooke@petermac.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: August 24, 2025
• Study Start: September 4, 2025
• Primary Completion: July 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

AU (1)