ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12623001164684

Ethics application status

Approved

Date submitted

11/10/2023

Date registered

9/11/2023

Date last updated

19/10/2024

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cancer

Condition category

Condition code

Cancer

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]

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]

Circulating Tumour Cell (CTC) count in CTC/ml

Timepoint [1]

3 months after implementation of the full ReDO protocol compared to baseline, that is 5 months after 0 months (baseline)

Primary outcome [2]

Circulating Tumour Cell (CTC) count in CTC/ml

Timepoint [2]

6 months after implementation of the full ReDO protocol compared to baseline, that is 8 months after 0 months (baseline)

Secondary outcome [1]

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]

5 and 8 months compared to baseline

Secondary outcome [2]

Cancer stage by tumour size and spread (Stage 1, 2, 3 or 4)

Timepoint [2]

5 and 8 months after baseline

Secondary outcome [3]

Quality of Life

Timepoint [3]

at 5 and 8 months compared to baseline

Secondary outcome [4]

Side effects of ReDO protocol

Timepoint [4]

daily during introductory 2 month period of ReDO drugs and nutrients, then weekly for 3-6 months

Secondary outcome [5]

Diet and Physical Activity Questionnaire

Timepoint [5]

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?

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

Recruiting

Date of first participant enrolment

Anticipated

14/10/2024

Actual

Date of last participant enrolment

Anticipated

30/10/2026

Actual

Date of last data collection

Anticipated

30/06/2027

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4209 - Willow Vale

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Patients at the Willow Vale Clinic

Address [1]

423 Ruffles Rd, Willow Vale, QLD 4209

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Taufiq Binjemain

Address

423 Ruffles Rd, Willow Vale, QLD 4209

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

National Institute of Integrative Medicine Human Research Ethics Committee (NIIM HREC)

Ethics committee address [1]

21 Burwood Rd, Hawthorn, VIC 3122, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/09/2023

Approval date [1]

07/03/2024

Ethics approval number [1]

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

A/Prof Dr Karin Ried

Address

National Institute of Integrative Medicine, 21 Burwood Rd, Hawthorn VIC 3122

Country

Australia

Phone

+61 399129545

Fax

karinried@niim.com.au

Contact person for public queries

Name

Taufiq BinJemain

Address

Willow Vale Clinic, 423 Ruffles Rd, Willow Vale, QLD 4209

Country

Australia

Phone

+61 473116849

Fax

info@willowvaleclinic.com.au

Contact person for scientific queries

Name

Taufiq BinJemain

Address

Willow Vale Clinic, 423 Ruffles Rd, Willow Vale, QLD 4209

Country

Australia

Phone

+61 473116849

Fax

info@willowvaleclinic.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24278	Ethical approval					386728-(Uploaded-14-10-2024-15-52-17)-0131N_2023_7.3.2024_Approval Letter_ReDOcancer Treatment Study_Karin Ried.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.

Trial Review

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