S0000D: Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000 (ACP)

SWOG Cancer Research Network

Status and phase: Completed; Phase 3

Conditions: Precancerous Condition; Colorectal Cancer

Treatments: Drug: Selenium; Drug: selenium placebo; Drug: Vitamin E; Drug: Vitamin E placebo

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00706121

CDR0000593329

S0000D (Other Identifier)

U10CA037429 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

RATIONALE: Studying tissue samples in the laboratory from participants receiving treatment on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000 may help doctors predict a participant's response to treatment and help plan the best treatment.

PURPOSE: This phase III trial is studying the effect of vitamin E and/or selenium on colorectal polyps in men enrolled on SELECT Trial SWOG-S0000.

Full description

OBJECTIVES:

Primary

• To assess the effect of selenium on colorectal adenoma (CRA) occurrence.
• To assess the effect of selenium on number, location, size, histologic type, and degree of dysplasia of CRA.
• To assess the effect of selenium on colorectal cancer (CRC) incidence.

Secondary

• To assess the effect of vitamin E on CRA occurrence.
• To assess the effect of vitamin E on CRC incidence.

Tertiary

• To explore the effect modification of selenium and vitamin E by aspirin on CRA occurrence.
• To explore the effect modification of selenium and vitamin E by body mass index.

OUTLINE: This is a multicenter study.

Endoscopically obtained tissue samples are reviewed by study pathologists to confirm the presence (or absence) of a colorectal adenoma (CRA). If a CRA is present, the number, location, size, histology, and degree of dysplasia are documented. The CRA is also reviewed to exclude a diagnosis of colorectal cancer.

Additional data, including aspirin use, height and weight, date of birth, and other demographic and baseline characteristics, is also obtained. Participants' medical records are reviewed periodically.

Participants are followed annually.

Enrollment: 8,094 patients

Sex: Male

Ages: 50 to 120 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Enrolled on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000
• Screened by lower endoscopy (i.e., sigmoidoscopy and/or colonoscopy) after randomization on SELECT trial

PATIENT CHARACTERISTICS:

• Willing to sign an applicable medical records release form
• Willing to allow the release of tissue for central pathology review of resected polyps and endoscopic biopsies

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8,094 participants in 4 patient groups, including a placebo group

Vitamin E + selenium placebo

Experimental group

Description:

Vitamin E and selenium placebo daily for 7 - 12 years

Treatment:

Drug: Vitamin E

Drug: selenium placebo

Selenium + vitamin E placebo

Experimental group

Description:

Selenium and vitamin E placebo daily for 7 - 12 years

Treatment:

Drug: Vitamin E placebo

Drug: Selenium

Vitamin E + selenium

Experimental group

Description:

Vitamin E and selenium daily for 7 - 12 years

Treatment:

Drug: Vitamin E

Drug: Selenium

Vitamin E placebo + selenium placebo

Placebo Comparator group

Description:

Vitamin E placebo and selenium placebo daily for 7 - 12 years

Treatment:

Drug: Vitamin E placebo

Drug: selenium placebo