Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001439831
Ethics application status
Approved
Date submitted
21/09/2021
Date registered
25/10/2021
Date last updated
9/05/2024
Date data sharing statement initially provided
25/10/2021
Date results information initially provided
9/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Light-bed Photodynamic Therapy (PDT) on Cancer
Scientific title
Monitoring treatment effect of photo-dynamic therapy using a light bed (Light-bed-PDT) in adult cancer patients by Circulating Tumour Cell (CTC) analysis, a randomized 2-month trial
Secondary ID [1] 305369 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 323708 0
Condition category
Condition code
Cancer 321244 321244 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cancer patients will undergo 2 sessions of Light-bed Photodynamic Therapy (PDT) on 2 consecutive days. Each PDT session consists of 2 steps. Step 1: oral administration of 5ml photosensitizer liquid containing 5mg of a chlorophyll-derivate extracted from algae. Step 2: followed by 30min of LED-Light-bed therapy 15-20 hours after dosing.
LED Light-bed therapy will be applied to the whole body using red light (630-700 nm).
SMS reminders will be sent to participants to assist with adherence to protocol.

Update to protocol after n=50 participants (half of target sample size): Participants are encouraged to consider Hyperbaric Oxygen Therapy (HBOT) immediately before Light-bed Therapy to enhance the therapeutic effect. While HBOT therapy is not part of this clinical trial, it will be noted whether participants have had a HBOT session before the Light-bed session. HBOT is provided as a clinical service, and all guidelines and eligibility criteria are to be adhered to.
Intervention code [1] 321779 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.
Control group
Active

Outcomes
Primary outcome [1] 329030 0
Number of CTC / CTC count by cytology
Timepoint [1] 329030 0
before, 1 week and 3 months after light-bed PDT treatment
Secondary outcome [1] 401863 0
Safety & tolerability will be assessed by our standard research side effects & tolerability questionnaire
Timepoint [1] 401863 0
immediately after each treatment session on days 1+2 and at follow-up at 1 week

Eligibility
Key inclusion criteria
adults diagnosed with cancer
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
This trial is using a pre-post study design where participants will act as their own control.
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Comparative analysis of CTC count before and after treatment. Descriptive analysis will be performed using SPPS (PASW version 26). This study will assess treatment effectiveness in a variety of cancer patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2021
Actual
20/12/2021
Date of last participant enrolment
Anticipated
21/12/2023
Actual
10/01/2024
Date of last data collection
Anticipated
1/03/2024
Actual
13/03/2024
Sample size
Target
100
Accrual to date
Final
91
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 35350 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 309739 0
Commercial sector/Industry
Name [1] 309739 0
RMWC Unlimited Innovation P/L
Country [1] 309739 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Institute of Integrative Medicine
Address
21 Burwood Rd
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 310760 0
None
Name [1] 310760 0
Address [1] 310760 0
Country [1] 310760 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309496 0
National Institute of Integrative Medicine
Ethics committee address [1] 309496 0
21 Burwood Rd
Hawthorn VIC 3122
Ethics committee country [1] 309496 0
Australia
Date submitted for ethics approval [1] 309496 0
14/09/2021
Approval date [1] 309496 0
10/11/2021
Ethics approval number [1] 309496 0
0093N_2021

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 2 sessions of Light-bed Photodynamic Therapy (PDT) on 2 consecutive days.
1. Photodynamic Therapy, which involves participants being given a chlorophyll-derived liquid food product which will help absorb light 15-20 hours before
2. LED Light-Bed whole body therapy, which involves lying in a red-light-bed for 30 min.
These treatments will be provided to participants 2 times on two consecutive days.

A blood test measuring the number of Circulating Tumour Cells (CTC) before and 3 weeks after treatment will assess treatment effectiveness. Fluorescence photography of the ear lobe will also be performed before and after treatment. Tolerability and safety will be assessed after each treatment session.

This study will provide insight into the safety and efficacy of Light-bed Photodynamic Therapy (PDT) in cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114354 0
A/Prof Karin Ried
Address 114354 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 114354 0
Australia
Phone 114354 0
+61 03 9912 9545
Fax 114354 0
Email 114354 0
[email protected]
Contact person for public queries
Name 114355 0
A/Prof Karin Ried
Address 114355 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 114355 0
Australia
Phone 114355 0
+61 03 9912 9545
Fax 114355 0
Email 114355 0
[email protected]
Contact person for scientific queries
Name 114356 0
A/Prof Karin Ried
Address 114356 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 114356 0
Australia
Phone 114356 0
+61 03 9912 9545
Fax 114356 0
Email 114356 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
Only summary data will be available. No individual data will be shared publicly. Individual data will be shared with the patient's doctor.


What supporting documents are/will be available?

No Supporting Document Provided



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.