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NCT Number: NCT07139782

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

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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Key information

Conditions

Head and Neck Cancer Fibrosis Head and Neck Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Fibrosis Syndrome Radiation Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Uptake (trial consent rate)

    Time frame: Throughout the trial for 12-months of recruitment

    Consent rate and reasons for declining trial participation

Secondary outcomes

  1. Adverse events

    Time frame: Throughout the trial for 12-months of recruitment

    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.

  2. Acceptability

    Time frame: Three months post baseline

    Assessed by inviting a subgroup of patients (n=15-20) to complete an individual semi-structured interview by telephone or videoconferencing.

  3. Program adherence

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

    The number of scheduled clinic and telehealth sessions attended

  4. Program adherence

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

    Adherence to prescribed unsupervised intervention (PBM) sessions

  5. Retention

    Time frame: 3-months post-baseline

    Patient retention at the follow-up assessment

  6. Neck circumference

    Time frame: Baseline and 3-months post-baseline

    Neck circumference to be measured using the Assessment of Lymphoedema of the Head and Neck (ALOHA) method

  7. Lymphoedema

    Time frame: Baseline and 3-months post-baseline

    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

  8. Percentage water content (PWC) of skin

    Time frame: Baseline and 3-months post-baseline

    Percentage water content of the skin to be performed using the Lymph Scanner

  9. Cervical spine range of motion

    Time frame: Baseline and 3-months post-baseline

    Neck range of motion to be measured with a digital goniometer

  10. Shoulder range of motion

    Time frame: Baseline and 3-months post-baseline

    Shoulder range of movement to be measured with a digital goniometer

  11. Trismus

    Time frame: Baseline and 3-months post-baseline

    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.

  12. Health-related quality of life

    Time frame: Baseline and 3-months post-baseline

    EORTC QLQ-HN43

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

61 3 8559 5234

Megan Howard

CONTACT

[email protected]

61 3 8559 5000

Sponsors and collaborators

Lead sponsor

Peter MacCallum Cancer Centre, Australia

Other

Registry information

Acronym: HOME-PBM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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