Selenium in the Prevention of Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00022165
First received: August 10, 2001
Last updated: February 6, 2009
Last verified: March 2002
  Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Selenium may be effective in preventing cancer. It is not yet known which dose of selenium may be most effective in preventing cancer.

PURPOSE: Randomized pilot study to determine the effectiveness of selenium in preventing cancer in healthy people.


Condition Intervention
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: selenium

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: Prevention Of Cancer By Intervention With Selenium

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 1999
Detailed Description:

OBJECTIVES: I. Determine whether daily supplementation with selenium significantly reduces total cancer incidence and site-specific cancer incidence in the general population. II. Determine whether this regimen has a beneficial effect on mood.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Participants are stratified according to age (60-64 vs 65-69 vs 70-74). Participants are randomized to one of four arms. Arm I: Participants receive oral placebo once daily. Arm II: Participants receive low-dose oral selenium once daily. Arm III: Participants receive moderate-dose oral selenium once daily. Arm IV: Participants receive high-dose oral selenium once daily. Treatment in all arms continues for up to 2 years in the absence of unacceptable side effects or diagnosis of cancer.

PROJECTED ACCRUAL: A total of 510 patients (170 per stratum) will be accrued for this study within 9-12 months.

  Eligibility

Ages Eligible for Study:   60 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Healthy men and women No prior diagnosis of cancer except non-melanoma skin cancer

PATIENT CHARACTERISTICS: Age: 60 to 74 Performance status: SWOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No active liver disease No known abnormal liver function Renal: No active kidney disease No known abnormal kidney function Other: HIV negative No diminished mental capacity that would preclude study

PRIOR CONCURRENT THERAPY: No other concurrent selenium supplements (50 ug/day or more)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022165

Locations
United Kingdom
Hammersmith Hospital
London, England, United Kingdom, W12 ONN
United Kingdom Coordinating Committee on Cancer Research-ABC
Sutton, England, United Kingdom, SM2 5NG
University Of Surrey
Guildford, United Kingdom, GU2 5XH
Sponsors and Collaborators
University of Surrey
Investigators
Study Chair: Margaret Rayman, DPhil University of Surrey
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00022165     History of Changes
Other Study ID Numbers: CDR0000068791, SURREY-UK-PRECISE, EU-20113
Study First Received: August 10, 2001
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on September 16, 2014