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.
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
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
Single group
Riancorp LTU-904 Laser and Handycure® (Medical Quant)
DeviceRiancorp: 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.
Uptake (trial consent rate)
Consent rate and reasons for declining trial participation
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.
Acceptability
Assessed by inviting a subgroup of patients (n=15-20) to complete an individual semi-structured interview by telephone or videoconferencing.
Program adherence
The number of scheduled clinic and telehealth sessions attended
Program adherence
Adherence to prescribed unsupervised intervention (PBM) sessions
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This trial is not recruiting at the moment. You can still explore other options:
