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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04952129




Registration number
NCT04952129
Ethics application status
Date submitted
14/06/2021
Date registered
7/07/2021
Date last updated
8/05/2024

Titles & IDs
Public title
Optimal Selenium for Bowel Polyps (OSCAR)
Scientific title
Randomised Phase Ib Trial to Determine the Optimal Selenium Status to Prevent Colorectal Adenoma Recurrence: OSCAR
Secondary ID [1] 0 0
OSCAR
Universal Trial Number (UTN)
Trial acronym
OSCAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Adenoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Plasma SEPP1 concentration 1
Timepoint [1] 0 0
At 6 weeks
Primary outcome [2] 0 0
Plasma SEPP1 concentration 2
Timepoint [2] 0 0
At 6 and 12 weeks
Primary outcome [3] 0 0
Plasma SEPP1 concentration 3
Timepoint [3] 0 0
At 6 and 12 weeks
Secondary outcome [1] 0 0
Plasma selenium
Timepoint [1] 0 0
At 6 and 12 weeks
Secondary outcome [2] 0 0
Treatment-emergent adverse effects
Timepoint [2] 0 0
At all time points
Secondary outcome [3] 0 0
White blood cell DNA damage
Timepoint [3] 0 0
At 6 and 12 weeks
Secondary outcome [4] 0 0
Recruitment
Timepoint [4] 0 0
At baseline

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.
Minimum age
60 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Waikato
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cancer Trials New Zealand
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Counties Manukau Health
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Waikato Hospital
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04952129
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Jameson, PhD
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries