Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001164684p
Ethics application status
Submitted, not yet approved
Date submitted
11/10/2023
Date registered
9/11/2023
Date last updated
9/11/2023
Date data sharing statement initially provided
9/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing treatment effectiveness of the 'Repurposing-Drugs-in-Oncology' (ReDO) protocol for cancer: The ReDO cancer treatment study
Scientific title
Assessing treatment effectiveness of the 'Repurposing-Drugs-in-Oncology' (ReDO) protocol for adult cancer by Circulating Tumour Cell (CTC) analysis: A case-series
Secondary ID [1] 310769 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 331727 0
Condition category
Condition code
Cancer 328474 328474 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The REDO Protocol consists of 19 medication (a) and nutrients (b) , introduced one item at the time, each item 3 days apart with side effects monitored over a period of 2 months. The full ReDO protocol (19 items) consists of the following dosages per day administered for 3 months (90 days).
All items are administered as oral tablets, with the exception of item 19, which is provided as oil.
Order of items in 2 month introduction period / Item / Dosage per day:
a) Prescription medication
1 Dichloroacetate 500 mg x2
2 Propanolol 40mg x 2
3 Metformin 500 mg x 1; 500 mg x 2
4 Atorvastatin (+ CoQ10) 20 mg/ night; 2x 20 mg
7 Sodium Phenylbutyrate 1-4 g/ night
8 Dipyridamole 2x 100 mg/ day; 2x200 mg
9 Hydroxychloroquine 200 mg /night
10 Ivermectin 25 mg/night
11 Melatonin 100mg
12 Doxycycline 50 mg x2
13 Mebendazole / Fenbendazole 100 mg x2
17 Loratadine (Anti-histamine) 20 mg x 2

b) Natural herbal supplements
5 Genistein 100mg x 3
6 D-Mannose 2x 1000 mg
14 Vitamin A (Retinoic Acid) 35,000 IU - 1 week on 1 week off
15 Berberine 2x 500mg
16 Epigallocatechin Gallate (EGCG) = green tea extract 400 mg x2
18 Hydroxy-citrate (Garcinia cambogia) 1000 mg x 2
19 Nigella Sativa Black Seed Oil 5ml x2

Compliance will be monitored by an online participant diary app.
Intervention code [1] 327174 0
Treatment: Drugs
Comparator / control treatment
The patients are their own control. Treatment effectiveness will be assessed by comparison of Cancer status, Circulating Tumour Cell (CTC) count, and Quality of Life, before and after the intervention(s),
Control group
Active

Outcomes
Primary outcome [1] 336305 0
Circulating Tumour Cell (CTC) count in CTC/ml
Timepoint [1] 336305 0
3 months after implementation of the full ReDO protocol compared to baseline, that is 5 months after 0 months (baseline)
Primary outcome [2] 336306 0
Circulating Tumour Cell (CTC) count in CTC/ml
Timepoint [2] 336306 0
6 months after implementation of the full ReDO protocol compared to baseline, that is 8 months after 0 months (baseline)
Secondary outcome [1] 427792 0
Tumour markers as relevant for the patient's cancer type, e.g. CA-125 for ovarian cancer, CEA for colorectal cancer, etc. Each tumour marker has their own related reference range, elevated levels are an indicator of tumour risk.
Timepoint [1] 427792 0
5 and 8 months compared to baseline
Secondary outcome [2] 427793 0
Cancer stage by tumour size and spread (Stage 1, 2, 3 or 4)
Timepoint [2] 427793 0
5 and 8 months after baseline
Secondary outcome [3] 427794 0
Quality of Life
Timepoint [3] 427794 0
at 5 and 8 months compared to baseline
Secondary outcome [4] 427798 0
Side effects of ReDO protocol
Timepoint [4] 427798 0
daily during introductory 2 month period of ReDO drugs and nutrients, then weekly for 3-6 months
Secondary outcome [5] 428500 0
Diet and Physical Activity Questionnaire
Timepoint [5] 428500 0
at 2, 5 and 8 months compared to baseline

Eligibility
Key inclusion criteria
diagnosed with cancer
suggested for the ReDO protocol by the investigating doctor
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
planning to start cancer treatments other than the ReDO protocol in the next 5 months

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
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
SPSS Statistical software version 29 will be used. For continuous variable we will analyse data by ANCOVA repeated measures of covariance, or repeated measures t-test. For categorical variables we will use Chi-square testing.
Primary outcome measures: Comparative analysis of CTC count (quantitative) and CTC morphology (qualitative) between sample 2 and 3 (5 and 8 months) versus sample 1 (baseline).
Secondary outcome measures: Cancer scans, tumour marker, and quality of life at baseline, 5 and 8 months compared to baseline.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2023
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 41547 0
4209 - Willow Vale

Funding & Sponsors
Funding source category [1] 314998 0
Other
Name [1] 314998 0
Patients at the Willow Vale Clinic
Country [1] 314998 0
Australia
Primary sponsor type
Individual
Name
Dr Taufiq Binjemain
Address
423 Ruffles Rd, Willow Vale, QLD 4209
Country
Australia
Secondary sponsor category [1] 317018 0
None
Name [1] 317018 0
Address [1] 317018 0
Country [1] 317018 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313971 0
National Institute of Integrative Medicine Human Research Ethics Committee (NIIM HREC)
Ethics committee address [1] 313971 0
21 Burwood Rd, Hawthorn, VIC 3122, Australia
Ethics committee country [1] 313971 0
Australia
Date submitted for ethics approval [1] 313971 0
05/09/2023
Approval date [1] 313971 0
Ethics approval number [1] 313971 0
0131N-2023

Summary
Brief summary
Background
The ReDO protocol is an abbreviation for ‘Repurposing Drugs in Oncology’, which is an ongoing worldwide project to find off-patent drugs that have anti-cancer effects. The ReDO protocol consists of multiple medication and nutrients, which are already approved by the FDA and TGA and have been used individually clinically for decades for a variety of clinical conditions.

The Study
This trial will be one of a number of clinical trials around the world to use a combination of medications and supplements to see if the ReDO protocol has any effects on cancer status. Each trial uses their own unique combination of medication and nutrients. This trial will use a combination of 19 medication and nutrients. Cancer status is measured by Circulating Tumour Cells (CTC) found in the blood, other cancer markers and standard diagnostic tools such as imaging.

Who is it for?
You may be eligible for this study if you are an adult who has been diagnosed with any cancer, and are able to come to the Willow Vale Clinic at the Gold Coast in QLD.

Study details
All participants in this study will be asked to commence use of 19 medications/supplements, one at at time, over a period of two months. Once participants have successfully used all medications/supplements, they will continue to take these for three to six months.

Throughout this time, participants will be followed up via blood tests, scans, and questionnaires to monitor side effects, cancer status and quality of life.

It is hoped that this study will systematically investigate the effectiveness of the updated ReDO protocol, consisting of 19 medication and nutrients, on cancer cell count, a biomarker for cancer status togather with other standard diagnostic tests.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129970 0
A/Prof Dr Karin Ried
Address 129970 0
National Institute of Integrative Medicine, 21 Burwood Rd, Hawthorn VIC 3122
Country 129970 0
Australia
Phone 129970 0
+61 399129545
Fax 129970 0
Email 129970 0
karinried@niim.com.au
Contact person for public queries
Name 129971 0
Dr Taufiq BinJemain
Address 129971 0
Willow Vale Clinic, 423 Ruffles Rd, Willow Vale, QLD 4209
Country 129971 0
Australia
Phone 129971 0
+61 473116849
Fax 129971 0
Email 129971 0
info@willowvaleclinic.com.au
Contact person for scientific queries
Name 129972 0
Dr Taufiq BinJemain
Address 129972 0
Willow Vale Clinic, 423 Ruffles Rd, Willow Vale, QLD 4209
Country 129972 0
Australia
Phone 129972 0
+61 473116849
Fax 129972 0
Email 129972 0
info@willowvaleclinic.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?

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.