Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000560998
Ethics application status
Approved
Date submitted
16/04/2009
Date registered
1/06/2011
Date last updated
10/05/2019
Date data sharing statement initially provided
10/05/2019
Date results information initially provided
10/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Resveratrol in the prevention of colorectal polyps
Scientific title
Resveratrol in the chemoprevention of colorectal neoplasia in people with high risk of colorectal cancer including carriers of Hereditary Non-polyposis Colorectal Cancer and their families, people who have had colorectal cancer and people who have had colorectal polyps
Secondary ID [1] 262290 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
high risk/familial risk of colorectal cancer 4613 0
Condition category
Condition code
Oral and Gastrointestinal 4912 4912 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 268128 268128 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will recruit 128 participants with a family history of colorectal cancer. The trial will be a randomized double blind, parallel design intervention after a 3-week washout period on a controlled diet. The controlled diet to be used was developed by Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition and this will be matched against known ingredients high in phenolic compounds. Blood and rectal biopsy samples will be collected for mucosal biomarkers measures. Randomized interventions will follow for 6 weeks with 100mL of dealcoholised red wine containing 50 mg resveratrol or a placebo consumed daily with the evening meal. Blood and biopsies will then be done again. The use of de-alcoholised wine will remove any risk of alcohol toxicity or cancer induction risk.
Intervention code [1] 4376 0
Prevention
Comparator / control treatment
placebo - wine containing no resveratrol
Control group
Placebo

Outcomes
Primary outcome [1] 5757 0
inflammation biomarkers (eg IL-6, CRP) , through rectal biopsies
Timepoint [1] 5757 0
at six weeks on conclusion of intervention
Primary outcome [2] 5758 0
expression of genes involved in normal structure and function of colorectal epithelium altered early in colorectal carcinogenesis, through rectal biopsies (Ki67 and TGF markers, apotosis markers Bax, Bc12 and bak, APC, beta-catenin and mismatch repair proteins)
Timepoint [2] 5758 0
at six weeks on conclusion of intervention
Primary outcome [3] 5759 0
colorectal epithelial crypt cell cycle events, through rectal biopsies
Timepoint [3] 5759 0
at six weeks on conclusion of intervention
Secondary outcome [1] 241713 0
local growth factor biomarkers, through rectal biopsies
Timepoint [1] 241713 0
at six weeks on conclusion of intervention

Eligibility
Key inclusion criteria
HNPCC carriers
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
pregnancy, co-morbidities

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation is concealed. Allocation involves contacting the holder of the allocation schedule who is "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/05/2009
Actual
19/10/2009
Date of last participant enrolment
Anticipated
Actual
10/11/2014
Date of last data collection
Anticipated
Actual
12/01/2015
Sample size
Target
128
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 4796 0
Government body
Name [1] 4796 0
Cancer Australia
Country [1] 4796 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
Royal Melbourne Hospital City Campus, Grattan St, Parkville. Vic 3050
Country
Australia
Secondary sponsor category [1] 4329 0
Commercial sector/Industry
Name [1] 4329 0
Australian Wine Research Insititute
Address [1] 4329 0
PO Box 197, Glen Osmond SA 5064
Country [1] 4329 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6844 0
Melbourne Health Research Directorate
Ethics committee address [1] 6844 0
6 East, City Campus, Grattan St, Parkville Royal Melbourne Hospital, Vic. 3050
Ethics committee country [1] 6844 0
Australia
Date submitted for ethics approval [1] 6844 0
30/01/2009
Approval date [1] 6844 0
22/04/2009
Ethics approval number [1] 6844 0
2009.023

Summary
Brief summary
This study aims to determine whether Resveratrol (contained in red wine) may prevent colorectal cancer in people with a family history of the disease.

Who is it for?
You can join this study if you are aged 18 years or more and are a carrier of hereditary non-polyposis colorectal cancer (HNPCC).

Trial details
Participants in this trial will eat a controlled diet developed by the CSIRO for a period of 3 weeks. They will then be randomly (by chance) divided into two groups. One group will consume 100ml of dealcoholised red wine containing 50 mg resveratrol daily with their evening meal for a period of 6 weeks. Participants in the other group will consume a placebo (sham) drink containing no resveratrol. Participants will not know which group they are in.

Blood and rectal biopsy samples will be taken from participants at the beginning and end of this study to assess any changes in markers associated with colorectal cancer.
Trial website
none
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29498 0
Prof Finlay Macrae
Address 29498 0
Level 3 Centre,
Department of Colorectal Medicine & Genetics
Royal Melbourne Hosptial
Parkville, VIC, 3050
Country 29498 0
Australia
Phone 29498 0
03 9342 8995
Fax 29498 0
Email 29498 0
[email protected]
Contact person for public queries
Name 12745 0
Prof Finlay Macrae
Address 12745 0
Department of Colorectal Medicine & Genetics
Grattan St
The Royal Melbourne Hospital
Parkville
Vic 3050
Country 12745 0
Australia
Phone 12745 0
+61 3 9342 7580
Fax 12745 0
+61 3 93427848
Email 12745 0
[email protected]
Contact person for scientific queries
Name 3673 0
Ms Creina Stockley
Address 3673 0
The Australian Wine Research Institute
PO Box 197, Glen Osmond SA 5064
Country 3673 0
Australia
Phone 3673 0
+61 8 83136612
Fax 3673 0
+61 8 83136601
Email 3673 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
It is not planned that IPD sharing will be available publically for this study.


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.