Randomised Phase Ib Trial to Determine the Optimal Selenium Status to Prevent Colorectal Adenoma Recurrence
New Zealand 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 main objective of this trial is to evaluate which dose and type of selenium (either selenomethionine or methylselenocysteine) gives optimal selenium status to maximise cancer prevention without causing health problems from excessive selenium intake. We also want to see how much selenium is needed according to selenium blood levels before starting selenium in the trial. Side effects will be evaluated, as will recruitment rates.
This will determine the feasibility of developing a large randomised trial of selenium to reduce the recurrence rates for advanced adenomas in NZ.
This trial will recruit 60 patients from Middlemore and Waikato Hospitals with an advanced adenoma removed through the Bowel Screening Programme. Patients will take one selenium compound, dosed at 50 mcg/day for 6 weeks then 100 mcg/day for 6 weeks, and will have blood tests at baseline, then blood tests and evaluation of side effects at 6 weeks and 12 weeks.
Waikato and Middlemore Hospitals
Dr Michael Jameson (Waikato District Health Board)
|Contact:||Shani Peleg (firstname.lastname@example.org)|
|Sponsor:||University of Auckland|
Centre for Cancer Research (University of Auckland)
|Trial Registry reference:||NCT04952129 (click for more details)|