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Genital Diseases, Male

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Male Urogenital Diseases

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Selenium

Selenomethylselenocysteine

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Trace Elements

Cysteine

Participants receive Se-methyl-seleno L-cysteine on days 1-84.

Participants receive selenomethionine PO on days 1-84.

Participants receive placebo PO on days 1-84.

Placebo

Laboratory Biomarker Analysis

Pharmacological Study

Methylselenocysteine

Raymond Bergan

This randomized phase I trial studies the side effects and the best dose of Se-methyl-seleno-L-cysteine or selenomethionine in preventing prostate cancer in healthy participants. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of Se-methyl-seleno-L-cysteine or selenomethionine, two different types of selenium compounds, may prevent prostate cancer from forming.

PRIMARY OBJECTIVES:

I. To determine the individual toxicity profiles of Se-methyl-seleno-L-cysteine (methyl selenocysteine; MSC) and selenomethionine (SeMet) administered to cohorts of men daily for twelve weeks, with dose escalation with each successive cohort.

SECONDARY OBJECTIVES:

I. To measure the pharmacokinetics of selenium, according to form (MSC vs SeMet): MSC and SeMet impacts on plasma, albumin, and urinary concentrations of selenium over 48 hours on dosing days 1 and 84.

II. To evaluate the pharmacodynamics of selenium by form (MSC vs SeMet): plasma, albumin, and urinary Selenoprotein P (Sepp1) concentrations and glutathione peroxidase (GPx) activity over 48 hours on dosing days 1 and 84.

III. To store plasma and formed elements (red cells plus platelets) for future analysis of methyl selenol and other key selenium species, when those assays become available.

OUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 3 treatment arms.

ARM I: Participants receive Se-methyl-seleno-L-cysteine orally (PO) on days 1-84.

ARM II: Participants receive selenomethionine PO on days 1-84.

ARM III: Participants receive placebo PO on days 1-84.

After completion of study treatment, patients are followed up on day 112.

Se-Methyl-Seleno-L-Cysteine or Selenomethionine in Preventing Prostate Cancer in Healthy Participants

Phase I Multiple Dose Study of 12-Week Treatment by Se-Methyl-L-Cysteine(MSC) and L SeMet in Adult Males

The safety and tolerability data will be summarized using descriptive statistics, by cohort and for all cohorts combined compared to placebo. Reported adverse events will be looked at for possible differences, where appropriate, using graphical methods.

The pharmacokinetic variables will be tabulated, and descriptive statistics calculated for each cohort, using established pharmacokinetic analysis methods. Plasma and urine pharmacokinetic parameters will be summarized graphically and by arithmetic or geometric means and coefficients of variations for each cohort.

National Cancer Institute (NCI)

Symptoms and General Pathology

Adenoma

Recurrence

Polyps

Intestinal Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Selenocysteine

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.

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.

Selenomethionine

Michael Jameson, PhD

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).

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:

1. Se 50 µg/day for 6 weeks significantly increases plasma selenoprotein P (SEPP) from baseline;
2. 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;
3. the increase in plasma SEPP from baseline is not different between MSC and SLM at each dose level.

Secondary objectives:

To determine:

1. change in plasma Se levels by Se type and dose;
2. change in white blood cell DNA damage from baseline by Se type and dose;
3. feasibility (assessed by recruitment rates, adverse events, compliance with trial medication and participant experience).

Trial assessments:

* blood tests at baseline, then 6 weeks and 12 weeks after initiating Se dosing;
* adverse events and trial medication compliance assessed 6 weeks and 12 weeks after initiating Se dosing;
* participant experience survey on completion of trial medication dosing.

Optimal Selenium for Bowel Polyps (OSCAR)

Randomised Phase Ib Trial to Determine the Optimal Selenium Status to Prevent Colorectal Adenoma Recurrence: OSCAR

To determine whether 50 micrograms/day of selenium for 6 weeks significantly increases plasma SEPP1 from baseline.

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.

To determine whether the change in plasma SEPP1 from baseline is not different between methylselenocysteine and selenomethionine at each dose.

To determine change in plasma selenium levels by selenium type and dose.

To determine the incidence of treatment-emergent adverse effects as classified according to NCI-CTCAE version 5.0

To determine change in DNA damage (relative to baseline) by selenium type and dose.

To determine to percentage of subjects who after being offered the study continue on to study entry.

Cancer Trials New Zealand

Counties Manukau Health

Waikato Hospital

University of Auckland, New Zealand

Associate Professor

Skin and Connective Tissue Diseases

Breast Neoplasms

Estrogens

Howard M. Kipen, MD, MPH

Helmut Zarbl, MD

The primary objective of this study is to determine if vitamin supplementation with a naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine) can restore disruption of circadian rhythm in shift workers.

All living cells have a circadian (daily) rhythm which controls a variety of bodily functions that change throughout the day, including body temperature, sleep, hunger, activity, hormone levels, etc. The circadian rhythm of the body is controlled by the amount of light that enters our eyes, so on our planet the length of the rhythm is 24 hours long. It is therefore reasonable to suspect that upsetting the timing of the rhythm would lead to changes in body function (as commonly experienced in "jet lag") and that prolonged changes might even lead to alterations in bodily functions and contribute to disease. This suggests that people whose service to the community that requires that they often work at night (nurses, doctors, police, hospital staff, firefighters, airline crews, factory workers, etc), might be at elevated risk of developing diseases. Studies have shown that women who do shift work have an elevated risk of breast cancer, probably as a result of altered hormone levels and cycling. Other studies have shown that vitamin supplementation with a naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine) can restore this disrupted rhythm and possibly decrease this disease risk. Thus, the purpose of this study is to investigate whether taking daily selenium (i.e., methylselenocysteine) will restore the disrupted circadian rhythm in shift workers.

Methylselenocysteine Effects on Circadian Rhythm

Chemoprevention of Breast and Prostate Cancers in Shift Workers by Dietary Methylselenocysteine: Effects on Circadian Rhythm and Estrogen Receptor-B Cycling

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Se-Methyl-Seleno-L-Cysteine or Selenomethionine in Preventing Prostate Cancer in Healthy Participants	NCT01497431	No Evidence of ... Prostate Carcin...	Selenium Placebo Laboratory Biom... Pharmacological... Methylselenocys...	40 Years - 80 Years	National Cancer Institute (NCI)
Optimal Selenium for Bowel Polyps (OSCAR)	NCT04952129	Colorectal Aden...	Selenomethionin... Methylselenocys...	60 Years - 74 Years	University of Auckland, New Zealand
Methylselenocysteine Effects on Circadian Rhythm	NCT01611038	Breast Cancer Prostate Cancer	Methylselenocys... Placebo	21 Years - 60 Years	Rutgers, The State University of New Jersey
Optimal Selenium for Bowel Polyps (OSCAR)	NCT04952129	Colorectal Aden...	Selenomethionin... Methylselenocys...	60 Years - 74 Years	University of Auckland, New Zealand
Optimal Selenium for Bowel Polyps (OSCAR)	NCT04952129	Colorectal Aden...	Selenomethionin... Methylselenocys...	60 Years - 74 Years	University of Auckland, New Zealand

Spots Global Cancer Trial Database for methylselenocysteine