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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04952129
Registration number
NCT04952129
Ethics application status
Date submitted
14/06/2021
Date registered
7/07/2021
Titles & IDs
Public title
Optimal Selenium for Bowel Polyps (OSCAR)
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Scientific title
Randomised Phase Ib Trial to Determine the Optimal Selenium Status to Prevent Colorectal Adenoma Recurrence: OSCAR
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Secondary ID [1]
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OSCAR
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Universal Trial Number (UTN)
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Trial acronym
OSCAR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal Adenoma
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Metabolic and Endocrine
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Other endocrine disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Selenomethionine
Treatment: Drugs - Methylselenocysteine
Experimental: Selenomethionine - 50 micrograms of selenium as Selenomethionine per oral capsule. Dosage: One capsule a day for 6 weeks, followed by two capsules per day for 6 weeks.
Experimental: Methylselenocysteine - 50 micrograms of selenium as Methylselenocysteine per oral capsule. Dosage: One capsule a day for 6 weeks, followed by two capsules per day for 6 weeks.
Treatment: Drugs: Selenomethionine
Seleno-amino acid
Treatment: Drugs: Methylselenocysteine
Seleno-amino acid
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Plasma SEPP1 concentration 1
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Assessment method [1]
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To determine whether 50 micrograms/day of selenium for 6 weeks significantly increases plasma SEPP1 from baseline.
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Timepoint [1]
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At 6 weeks
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Primary outcome [2]
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Plasma SEPP1 concentration 2
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Assessment method [2]
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To determine whether the change in plasma SEPP1 from baseline is greater with selenium 100 micrograms/day than 50 micrograms/day only when baseline plasma selenium is below the median value for the trial population.
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Timepoint [2]
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At 6 and 12 weeks
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Primary outcome [3]
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Plasma SEPP1 concentration 3
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Assessment method [3]
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To determine whether the change in plasma SEPP1 from baseline is not different between methylselenocysteine and selenomethionine at each dose.
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Timepoint [3]
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At 6 and 12 weeks
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Secondary outcome [1]
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Plasma selenium
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Assessment method [1]
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To determine change in plasma selenium levels by selenium type and dose.
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Timepoint [1]
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At 6 and 12 weeks
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Secondary outcome [2]
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Treatment-emergent adverse effects
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Assessment method [2]
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To determine the incidence of treatment-emergent adverse effects as classified according to NCI-CTCAE version 5.0
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Timepoint [2]
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At all time points
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Secondary outcome [3]
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White blood cell DNA damage
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Assessment method [3]
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To determine change in DNA damage (relative to baseline) by selenium type and dose.
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Timepoint [3]
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At 6 and 12 weeks
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Secondary outcome [4]
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Recruitment
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Assessment method [4]
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To determine to percentage of subjects who after being offered the study continue on to study entry.
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Timepoint [4]
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At baseline
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Eligibility
Key inclusion criteria
Participants will have all of the following:
* pathologically-confirmed advanced adenoma (defined as any one of >/= 10mm diameter, >/= 3 adenomas, high-grade dysplasia, tubulovillous or villous adenoma) 5 diagnosed at first colonoscopy in the National bowel screening programme within the previous 6 months;
* no residual colorectal adenomas;
* next colonoscopy planned within 5 years;
* willing and able to comply with all trial requirements, including treatment and assessments;
* signed written, informed consent.
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Minimum age
60
Years
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Maximum age
74
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants will have none of the following:
* currently taking selenium supplements (including in multivitamins) or within the last 6 weeks;
* previous history of colorectal adenoma, colorectal cancer or familial colorectal cancer syndrome;
* other significant cancers within the last 5 years;
* concurrent medical conditions that, in the opinion of the investigators, would compromise either participant safety or the integrity of the data (e.g., malabsorption);
* male participants with a female partner of childbearing potential or pregnant, and unwilling to remain abstinent or use effective contraception (including barrier contraception with a pregnant partner).
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/05/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
56
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Waikato
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Country [2]
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New Zealand
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State/province [2]
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Auckland, New Zealand
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Cancer Trials New Zealand
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Counties Manukau Health
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Waikato Hospital
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
New Zealand (NZ) has high bowel cancer rates, which the Bowel Screening Programme aims to reduce by early detection of bowel cancer and its precursor, adenomas (polyps). Bowel cancer and adenoma rates are higher in countries like NZ with low intake of the essential trace mineral selenium. Overseas, trials of selenium supplements reduced adenoma recurrence in people with low blood selenium, but not with high levels (where adding selenium increased health risks). Laboratory research explained this, and found certain types of selenium are safer and more effective. The optimal type and dose of selenium to use in NZ cancer prevention trials is not known. The goal of this clinical trial is to find out how to achieve the optimal amount of body selenium in people who have had a high risk bowel adenoma removed. The main questions it aims to answer are: * what dose of selenium taken by mouth will maximise levels of the main selenium protein in blood; * whether one type of organic selenium is better than the other at increasing blood levels of this selenium protein; * whether a larger dose of selenium is needed in people who start with lower blood selenium levels; Participants will take one selenium capsule a day for 6 weeks then two capsules a day for 6 weeks. Each participant will have blood tests at baseline, then blood tests and evaluation of side effects at 6 weeks and 12 weeks. Researchers will compare these results in the participants taking each type of selenium (selenomethionine or methylselenocysteine).
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Trial website
https://clinicaltrials.gov/study/NCT04952129
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Michael Jameson, PhD
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Address
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University of Auckland, New Zealand
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04952129