Optimal Selenium for Bowel Polyps (OSCAR) (OSCAR)

• ClinicalTrials.gov Identifier: NCT04952129
• Recruitment Status: Not yet recruiting
• First Posted: July 7, 2021
• Last Update Posted: July 14, 2021
• Sponsor: University of Auckland, New Zealand
• Collaborators: Cancer Trials New Zealand; Counties Manukau Health; Waikato Hospital
• Information provided by (Responsible Party): Michael Jameson, University of Auckland, New Zealand

Tracking Information

• First Submitted Date: June 14, 2021
• First Posted Date: July 7, 2021
• Last Update Posted Date: July 14, 2021
• Estimated Study Start Date: August 1, 2021
• Estimated Primary Completion Date: February 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 27, 2021)

• Plasma SEPP1 concentration 1 [ Time Frame: At 6 weeks ]
  To determine whether 50 micrograms/day of selenium for 6 weeks significantly increases plasma SEPP1 from baseline.
• Plasma SEPP1 concentration 2 [ Time Frame: 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 [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 12, 2021)

• Plasma selenium [ Time Frame: At 6 and 12 weeks ]
  To determine change in plasma selenium levels by selenium type and dose.
• Treatment-emergent adverse effects [ Time Frame: At all time points ]
  To determine the incidence of treatment-emergent adverse effects as classified according to NCI-CTCAE version 5.0
• White blood cell DNA damage [ Time Frame: At 6 and 12 weeks ]
  To determine change in DNA damage (relative to baseline) by selenium type and dose.
• Recruitment [ Time Frame: At baseline ]
  To determine to percentage of subjects who after being offered the study continue on to study entry.

Original Secondary Outcome Measures (submitted: June 27, 2021)

• Plasma selenium [ Time Frame: At 6 and 12 weeks ]
  To determine change in plasma selenium levels by selenium type and dose.
• Safety of selenium compounds [ Time Frame: At all time points ]
  To determine the incidence of treatment-emergent adverse effects as classified according to NCI-CTCAE version 5.0
• White blood cell DNA damage [ Time Frame: At 6 and 12 weeks ]
  To determine change in DNA damage (relative to baseline) by selenium type and dose.
• Recruitment [ Time Frame: At baseline ]
  To determine to percentage of subjects who after being offered the study continue on to study entry.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Optimal Selenium for Bowel Polyps (OSCAR)
• Official Title: Randomised Phase Ib Trial to Determine the Optimal Selenium Status to Prevent Colorectal Adenoma Recurrence: OSCAR

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 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Colorectal Adenoma

Intervention

• Drug: Selenomethionine
  Seleno-amino acid
• Drug: Methylselenocysteine
  Seleno-amino acid

Study Arms

• 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.
  Intervention: Drug: Selenomethionine
• 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.
  Intervention: Drug: Methylselenocysteine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: June 27, 2021): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 1, 2022
• Estimated Primary Completion Date: February 1, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years to 74 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Michael Jameson, PhD; +64 7 8398750; michael.jameson@waikatodhb.health.nz

• Listed Location Countries: New Zealand

Administrative Information

• NCT Number: NCT04952129
• Other Study ID Numbers: OSCAR
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Michael Jameson, University of Auckland, New Zealand
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Auckland, New Zealand
• Original Study Sponsor: Same as current

Collaborators

• Cancer Trials New Zealand
• Counties Manukau Health
• Waikato Hospital

Investigators

• Principal Investigator: Michael Jameson, PhD; University of Auckland, New Zealand

• PRS Account: University of Auckland, New Zealand
• Verification Date: July 2021