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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
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
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
karinried@niim.com.au
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
karinried@niim.com.au
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
karinried@niim.com.au

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.