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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorPeter MacCallum Cancer Centre, Australia

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

30 Participants
are divided into 1 treatment group