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Optimal Selenium for Bowel Polyps (OSCAR) (OSCAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04952129
Recruitment Status : Not yet recruiting
First Posted : July 7, 2021
Last Update Posted : July 14, 2021
Sponsor:
Collaborators:
Cancer Trials New Zealand
Counties Manukau Health
Waikato Hospital
Information provided by (Responsible Party):
Michael Jameson, University of Auckland, New Zealand

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colorectal Adenoma Drug: Selenomethionine Drug: Methylselenocysteine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomised Phase Ib Trial to Determine the Optimal Selenium Status to Prevent Colorectal Adenoma Recurrence: OSCAR
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Selenomethionine
Seleno-amino acid
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.
 Drug: Methylselenocysteine
Seleno-amino acid


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Plasma selenium [ Time Frame: At 6 and 12 weeks ]
    To determine change in plasma selenium levels by selenium type and dose.

  2. 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

  3. 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.

  4. Recruitment [ Time Frame: At baseline ]
    To determine to percentage of subjects who after being offered the study continue on to study entry.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04952129


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

Locations
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New Zealand
Waikato DHB
Hamilton, Waikato, New Zealand, 3240
Contact: Michael Jameson, PhD    +64 7 8398750    michael.jameson@waikatodhb.health.nz   
Counties Manukau DHB
Auckland, New Zealand, 2025
Contact: Maree Weston, MBChB    +64 9 276 0000    Maree.Weston@middlemore.co.nz   
Sponsors and Collaborators
University of Auckland, New Zealand
Cancer Trials New Zealand
Counties Manukau Health
Waikato Hospital
Investigators
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Principal Investigator: Michael Jameson, PhD University of Auckland, New Zealand
More Information
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Responsible Party: Michael Jameson, Associate Professor, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT04952129    
Other Study ID Numbers: OSCAR
First Posted: July 7, 2021    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Michael Jameson, University of Auckland, New Zealand:
selenium
colorectal adenoma
selenomethionine
methylselenocysteine
selenoprotein P
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Selenium
Selenomethylselenocysteine
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Anticarcinogenic Agents
Antineoplastic Agents