None listed
Conditions
Brief summary
The prevalence of cancer diagnosis is high and attributable to 30% of all deaths in Australia. There is a need for better treatment combined with reliable assessments of treatment effectiveness. This pilot intervention study aims to assess the treatment effect and safety of Light-bed-PDT for patients with cancer using Circulating Tumour Cell (CTC) analyses. Who is it for? You may be eligible for this study, if you have been diagnosed with cancer. Study details Cancer patients will undergo 1x session of Light-bed Photodynamic Therapy (LBT) directly after Hyperbaric Oxygen Therapy (HBOT) Step 1 (Day 1 afternoon). Photodynamic Therapy, which involves participants being given a chlorophyll-derived liquid food product which will help absorb light 15-20 hours before step 3 Step 2 (Day 2 morning): 1x 60 min of Hyperbaric Oxygen Therapy (at 2 atmospheric pressure), immediately before Step 3. LED Light-Bed whole body therapy, which involves lying in a red-light-bed for 30 min. A blood test measuring the number of Circulating Tumour Cells (CTC) before and after treatment at 1 week and at 3 months will assess treatment effectiveness. Tolerability and safety will be assessed after each treatment session. This study will provide further insight into the safety and efficacy of Lightbed Photodynamic Therapy (LBT) after Hyperbaric Oxygen Therapy (HBOT) in cancer patients.
Interventions
Treatment consists of 1x cycle of 3 steps:
Step 1: Day 1 afternoon: oral administration of 10ml photosensitizer liquid containing 10mg of a chlorophyll-derivate extracted from algae, 16-20 hours before LBT (step3)
Step2 : Day 2 morning: 1x 60min Hyperbaric Oxygen Therapy Session (HBOT). Participants will lie supine in a Perry Oxygen Chamber, a clear acrylic plastic pressurised chamber, breathing in through a mask 100% oxygen at 2 atmospheric pressures.
Step 3: Day 2 straight after HBOT: 1x 30mi
Treatment consists of 1x cycle of 3 steps: Step 1: Day 1 afternoon: oral administration of 10ml photosensitizer liquid containing 10mg of a chlorophyll-derivate extracted from algae, 16-20 hours before LBT (step3) Step2 : Day 2 morning: 1x 60min Hyperbaric Oxygen Therapy Session (HBOT). Participants will lie supine in a Perry Oxygen Chamber, a clear acrylic plastic pressurised chamber, breathing in through a mask 100% oxygen at 2 atmospheric pressures. Step 3: Day 2 straight after HBOT: 1x 30min session of Lightbed Photodynamic Therapy (LBT) LED Light-bed therapy will be applied to the whole body using red light (630-800 nm). SMS reminders will be sent to participants to assist with adherence to protocol. HBOT is provided as a clinical service, and all guidelines and eligibility criteria are to be adhered to.
Sponsors
National Institute of Integrative Medicine
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
adults diagnosed with cancer; baseline CTC count before LBT treatment:: 5-20 CTC/ml suitable/ eligible for HBOT therapy (as per standard guidelines for HBOT, an accredited clinical service; e.g. no sinus blockage)
Exclusion criteria
planned other treatment including surgery within 1 week Porphyria Claustrophobia, anxiety Not able to provide consent
Outcome results
None listed