None listed
Conditions
Brief summary
The study aims to effectiveness the impact of light therapy, known as photobiomodulation (PBM), on recipients of allogeneic haematopoietic stem cell transplant (alloHSCT) in the prevention of oral mucositis. This work is important because oral mucositis is common, painful, costly, and a major cause of suffering during transplant care. PBM is a simple, quick, non invasive therapy with international guideline support but limited local use. Who is it for? You may be eligible for this study if you are an adult who is receiving allogeneic haematopoietic stem cell transplant at the Royal Adelaide Hospital. Study details Participants in this study will either receive current standard practice in the prevention and treatment of oral mucositis, or, they will receive current practice plus light therapy. Light therapy sessions will occur daily from the day of first chemotherapy session until 2 days after receiving the allogeneic haematopoietic stem cell transplant. Treatment sessions will take approximately 5 minutes and occur while the participant is an inpatient at the Royal Adelaide Hospital. Participants will then be followed up to determine if they are experiencing oral mucositis and data will be collected from medical records. The primary outcome of the study will be the incidence and duration of severe oral mucositis. It will also measure patient wellbeing, pain, nutrition, bacteraemia rates, hospital stay length, and how easily staff can adopt the treatment. It is hoped that this study will help provide clearer evidence on PBM’s real world effectiveness, data on costs and quality of life benefits, and practical information related to its implementation.
Interventions
In the intervention group, participants will receive Photobiomodulation (PBM) using the THOR Model LX2.3 unit (THOR Photomedicine Ltd, Chesham, UK).
The THOR LX2.3 is a TGA-approved device for the management of oral mucositis and consists of:
1. Extra-oral 104 Diode LED Cluster Probe
The probe contains two types of LED:
56 × 660 nm LEDs (average power 10 mW per LED)
48 × 850 nm LEDs (average power 30 mW per LED)
Total power output: 2000 mW
Average irradiance: 45 mW/cm²
2. Intra-oral LED Lolli
In the intervention group, participants will receive Photobiomodulation (PBM) using the THOR Model LX2.3 unit (THOR Photomedicine Ltd, Chesham, UK). The THOR LX2.3 is a TGA-approved device for the management of oral mucositis and consists of: 1. Extra-oral 104 Diode LED Cluster Probe The probe contains two types of LED: 56 × 660 nm LEDs (average power 10 mW per LED) 48 × 850 nm LEDs (average power 30 mW per LED) Total power output: 2000 mW Average irradiance: 45 mW/cm² 2. Intra-oral LED Lollipop Probe The probe contains two types of LED: 18 × 660 nm LEDs (average power 80 mW per LED) 23 × 850 nm LEDs (average power 60 mW per LED) Total power output: 2800 mW Average irradiance: 50 mW/cm² The treatment protocol is derived from the World Association for Photobiomodulation Therapy (WALT) Position Statement 2022 recommendations for the prevention of oral mucositis. PBM will be delivered to three extra-oral sites and two intra-oral sites, with treatment applied for 60 seconds per site. Each daily PBM session will therefore last 5 minutes in total, comprising: PBM is delivered to 3 extra-oral and 2 intra-oral sites for 60 seconds per site (5 minutes total treatment time). The delivered fluence is 2.7 J/cm² at each extra-oral site and 3.0 J/cm² at each intra-oral site. Based on total device outputs of 2.0 W and 2.8 W respectively, total energy delivered is 360 J to the extra-oral sites and 336 J to the intra-oral sites, for a total daily energy delivery of 696 J. PBM will be administered within 30–120 minutes prior to each chemotherapy dose. Treatment will commence on the first day of conditioning chemotherapy (Day -6) and continue until Day +2 following haematopoietic stem cell infusion, corresponding to a maximum treatment duration of 9 consecutive days. The intervention will be delivered by nursing staff who have completed competency-based training in the use of the PBM device. Fidelity of intervention delivery will be monitored using a daily treatment record completed by nursing staff documenting treatment completion, treatment timing, and any missed treatment sessions. This is a non-randomised study comprising separate control and intervention cohorts. Participants recruited prior to implementation of the PBM service will receive usual care and will form the control group (n=39). This cohort will be recruited during the period required for service implementation, including procurement of the PBM device and staff training. We anticipate this implementation period will be approximately nine months. Following implementation of the PBM service, a separate cohort of participants (n=39) will be recruited to receive PBM in addition to usual care and will form the intervention group. Allocation to the control or intervention group will therefore not be randomised. Group assignment will be determined by the timing of recruitment relative to implementation of the PBM service, with participants recruited before implementation assigned to the control group and participants recruited after implementation assigned to the intervention group.
Sponsors
The Royal Adelaide Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
18 years or older undergoing allo-HSCT at the Royal Adelaide Hospital.
Exclusion criteria
Are unable to give written informed consent Are unable to comprehend or record the self-reporting questionnaires, which will be used to assess quality of life Have a medical history of epilepsy or sensitivity to flashing lights Are intubated and ventilated via endotracheal tube Have a secondary malignancy in the oral cavity or on the face (in the area of treatment) which is not/has not actively been treated.
Outcome results
None listed