Colorectal Adenoma Clinical Trial
— OSCAROfficial title:
Randomised Phase Ib Trial to Determine the Optimal Selenium Status to Prevent Colorectal Adenoma Recurrence: OSCAR
Verified date | May 2024 |
Source | University of Auckland, New Zealand |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 56 |
Est. completion date | August 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 74 Years |
Eligibility | 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. 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). |
Country | Name | City | State |
---|---|---|---|
New Zealand | Counties Manukau DHB | Auckland | |
New Zealand | Waikato DHB | Hamilton | Waikato |
Lead Sponsor | Collaborator |
---|---|
University of Auckland, New Zealand | Cancer Trials New Zealand, Counties Manukau Health, Waikato Hospital |
New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma SEPP1 concentration 1 | To determine whether 50 micrograms/day of selenium for 6 weeks significantly increases plasma SEPP1 from baseline. | At 6 weeks | |
Primary | Plasma SEPP1 concentration 2 | 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. | At 6 and 12 weeks | |
Primary | Plasma SEPP1 concentration 3 | To determine whether the change in plasma SEPP1 from baseline is not different between methylselenocysteine and selenomethionine at each dose. | At 6 and 12 weeks | |
Secondary | Plasma selenium | To determine change in plasma selenium levels by selenium type and dose. | At 6 and 12 weeks | |
Secondary | Treatment-emergent adverse effects | To determine the incidence of treatment-emergent adverse effects as classified according to NCI-CTCAE version 5.0 | At all time points | |
Secondary | White blood cell DNA damage | To determine change in DNA damage (relative to baseline) by selenium type and dose. | At 6 and 12 weeks | |
Secondary | Recruitment | To determine to percentage of subjects who after being offered the study continue on to study entry. | At baseline |
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