Randomised Phase Ib Trial to Determine the Optimal Selenium Status to Prevent Colorectal Adenoma Recurrence: OSCAR
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Plasma SEPP1 concentration 2
研究概览
简要总结
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).
详细描述
The main aim of this trial is to evaluate which dose and type of selenium (Se), either selenomethionine or methylselenocysteine, achieves optimal selenium status, in order to maximise its potential for cancer prevention without causing health problems from excessive Se intake. The trial will also evaluate how much Se is needed according to Se blood levels before starting Se in the trial, adverse events and recruitment rates.
This trial will recruit 60 participants from Middlemore and Waikato Hospitals with at least one advanced colorectal adenoma removed through the Bowel Screening Programme. Participants will be randomised (1:1) to take either selenomethionine or methylselenocysteine, dosed at Se 50 mcg/day for 6 weeks then 100 mcg/day for 6 weeks.
Co-primary objectives:
To determine whether:
- Se 50 µg/day for 6 weeks significantly increases plasma selenoprotein P (SEPP) from baseline;
- the increase in plasma SEPP from baseline is greater with Se 100 µg/day than 50 µg/day only when baseline plasma Se is below the median value for the trial population;
- the increase in plasma SEPP from baseline is not different between MSC and SLM at each dose level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Selenomethionine (Drug)
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.
干预措施: Methylselenocysteine (Drug)
结局指标
主要结局
Plasma SEPP1 concentration 2
时间窗: At 6 and 12 weeks
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.
Plasma SEPP1 concentration 3
时间窗: At 6 and 12 weeks
To determine whether the change in plasma SEPP1 from baseline is not different between methylselenocysteine and selenomethionine at each dose.
Plasma SEPP1 concentration 1
时间窗: At 6 weeks
To determine whether 50 micrograms/day of selenium for 6 weeks significantly increases plasma SEPP1 from baseline.
次要结局
- White blood cell DNA damage(At 6 and 12 weeks)
- Plasma selenium(At 6 and 12 weeks)
- Treatment-emergent adverse effects(At all time points)
- Recruitment(At baseline)
研究者
Michael Jameson
Associate Professor
University of Auckland, New Zealand