Head and Neck Cancer
Conditions
Keywords
head and neck cancer, photo-biomodulation, radiation fibrosis, lymphoedema, physiotherapy
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.
Interventions
DEVICERiancorp 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.
Sponsors
Peter MacCallum Cancer Centre, Australia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patient has provided written informed consent using the HOME-PBM patient information and consent form 2. Patient is referred to the Lymphoedema Clinic for the management of head and neck lymphoedema and/or radiation fibrosis 3. Previously received curative-intent treatment (surgery and/or \[chemo\]radiotherapy) for mucosal head and neck cancer 4. Patient is able to attend appointments in person 5. Adults aged 18 years or older at Screening 6. Patient able to speak and read English
Exclusion criteria
1. 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) 2. Residual or recurrent disease within the head and neck 3. Has a diagnosis of photosensitive disorder (cutaneous porphyria, xeroderma pigmentosum, etc.) 4. Patient has tuberculosis or another form of virulent bacteria 5. Patient has a contraindication to receiving PBM treatment 6. Patient has no internet enabled device for telehealth video follow-up appointment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake (trial consent rate) | Throughout the trial for 12-months of recruitment | Consent rate and reasons for declining trial participation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | 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. |
| Program adherence | Throughout the trial for 12-months of recruitment and completion of 3-month follow-up | The number of scheduled clinic and telehealth sessions attended |
| Retention | 3-months post-baseline | Patient retention at the follow-up assessment |
| Neck circumference | Baseline and 3-months post-baseline | Neck circumference to be measured using the Assessment of Lymphoedema of the Head and Neck (ALOHA) method |
| Lymphoedema | 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 |
| Adverse events | 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. |
| Cervical spine range of motion | Baseline and 3-months post-baseline | Neck range of motion to be measured with a digital goniometer |
| Shoulder range of motion | Baseline and 3-months post-baseline | Shoulder range of movement to be measured with a digital goniometer |
| Trismus | 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. |
| Health-related quality of life | Baseline and 3-months post-baseline | EORTC QLQ-HN43 |
| Percentage water content (PWC) of skin | Baseline and 3-months post-baseline | Percentage water content of the skin to be performed using the Lymph Scanner |
Countries
Australia
Contacts
Primary ContactMegan Howard
Backup ContactLara Edbrooke, B App Sc (Physio), GDEB, PhD
Outcome results
None listed