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Trial registered on ANZCTR


Registration number
ACTRN12624000349549
Ethics application status
Approved
Date submitted
13/03/2024
Date registered
27/03/2024
Date last updated
11/08/2024
Date data sharing statement initially provided
27/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Light-bed Photodynamic Therapy (PDT) on Cancer - Phase 2
Scientific title
Assessing the effect of Photo-Dynamic Therapy (PDT) using a Lightbed (LBT) after Hyperbaric Oxygen Therapy (HBOT) in adult cancer patients by Circulating Tumour Cell (CTC) analysis
Secondary ID [1] 311726 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a follow-up study of ACTRN12621001439831, our first study titled "Effect of Light-bed Photodynamic Therapy (PDT) on Cancer".

Health condition
Health condition(s) or problem(s) studied:
Cancer 333210 0
Condition category
Condition code
Cancer 329898 329898 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328189 0
Treatment: Devices
Comparator / control treatment
Primary comparator: Patients are their own control. Treatment effectiveness will be assessed by Circulating Tumour Cell (CTC) count by blood test, by which the CTC count (number of CTC/ml) after treatment will be compared to the CTC count before treatment.
Control group
Active

Outcomes
Primary outcome [1] 337663 0
CTC count (number of CTC per ml) by cytology
Timepoint [1] 337663 0
before (within 2-4 weeks of) treatment, 1 week after and 3 months after lightbed treatment
Secondary outcome [1] 432748 0
Safety & tolerability
Timepoint [1] 432748 0
immediately after treatment and at follow-up at 1 week

Eligibility
Key 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)
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
planned other treatment including surgery within 1 week
Porphyria
Claustrophobia, anxiety
Not able to provide consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
31/03/2026
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 42237 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 316056 0
Commercial sector/Industry
Name [1] 316056 0
RMWC Unlimited Innovation P/L
Country [1] 316056 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Institute of Integrative Medicine
Address
Country
Australia
Secondary sponsor category [1] 318220 0
None
Name [1] 318220 0
Address [1] 318220 0
Country [1] 318220 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314876 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 314876 0
https://niim.com.au/research/niim-human-research-ethics-committee
Ethics committee country [1] 314876 0
Australia
Date submitted for ethics approval [1] 314876 0
13/02/2024
Approval date [1] 314876 0
27/02/2024
Ethics approval number [1] 314876 0
0137N_2024

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133022 0
A/Prof Karin Ried
Address 133022 0
National Institute of Integrative Medicine, 21 Burwood Rd, Hawthorn VIC 3122
Country 133022 0
Australia
Phone 133022 0
+61 399129545
Fax 133022 0
Email 133022 0
[email protected]
Contact person for public queries
Name 133023 0
Karin Ried
Address 133023 0
National Institute of Integrative Medicine, 21 Burwood Rd, Hawthorn VIC 3122
Country 133023 0
Australia
Phone 133023 0
+61 399129545
Fax 133023 0
Email 133023 0
[email protected]
Contact person for scientific queries
Name 133024 0
Karin Ried
Address 133024 0
National Institute of Integrative Medicine, 21 Burwood Rd, Hawthorn VIC 3122
Country 133024 0
Australia
Phone 133024 0
+61 399129545
Fax 133024 0
Email 133024 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21859Ethical approval    387491-(Uploaded-13-03-2024-13-12-14)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.