Design and baseline characteristics of participants in a phase III randomized trial of celecoxib and selenium for colorectal adenoma prevention

Patricia Thompson, Denise Roe, Liane Fales, Julie Buckmeier, Fang Wang, Stanley R. Hamilton, Achyut K Bhattacharyya, Sylvan Green, Chiu-Hsieh Hsu, Hsiao-Hui Chow, Dennis J. Ahnen, C. Richard Boland, Russell I. Heigh, David E. Fay, Maria Elena Martinez, Elizabeth T Jacobs, Erin L. Ashbeck, David S Alberts, Michael P Lance

Research output: Contribution to journalArticle

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Abstract

COX inhibitors reduce colorectal adenoma recurrence by up to 45% and selenium supplementation may prevent colorectal cancer. Following colonoscopic adenoma resection, 1,600 men and women, ages 40 to 80 years, were randomized to celecoxib (400 mg daily), a selective COX-2 inhibitor, and/or selenium (200 mg daily as selenized yeast), or double placebo. The trial was initiated in November 2001. The primary trial endpoint is adenoma recurrence in each intervention group compared with placebo, as determined by surveillance colonoscopy conducted three to five years after baseline. Randomization was stratified by use of low-dose aspirin (81 mg) and clinic site. Following reports of cardiovascular toxicity associated with COX-2 inhibitors, the celecoxib arm was discontinued in December 2004 when 824 participants had been randomized. Accrual continued with randomization to selenium alone or placebo. Randomization of the originally planned cohort (n = 1,621) was completed in November 2008. A further 200 patients with one or more advanced adenomas (denoting increased risk for colorectal cancer) were accrued to enhance statistical power for determining intervention efficacy in this higher-risk subgroup. Accrual of the total cohort (n = 1,824) was completed in January 2011. Baseline cohort characteristics include: mean age 62.9 years; 65% male; body mass index (BMI) 29.1 ± 5.1; 47% taking low-dose aspirin while on trial; 20% with three or more adenomas; and 38% with advanced adenomas. Intervention effects on adenoma recurrence will be determined, and their modification by genetic background and baseline selenium level. The effect of selenium supplementation on risk for type II diabetes will also be reported.

Original languageEnglish (US)
Pages (from-to)1381-1393
Number of pages13
JournalCancer Prevention Research
Volume5
Issue number12
DOIs
StatePublished - Dec 2012

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Celecoxib
Selenium
Adenoma
Random Allocation
Cyclooxygenase 2 Inhibitors
Placebos
Recurrence
Aspirin
Colorectal Neoplasms
Colonoscopy
Type 2 Diabetes Mellitus
Body Mass Index

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Design and baseline characteristics of participants in a phase III randomized trial of celecoxib and selenium for colorectal adenoma prevention. / Thompson, Patricia; Roe, Denise; Fales, Liane; Buckmeier, Julie; Wang, Fang; Hamilton, Stanley R.; Bhattacharyya, Achyut K; Green, Sylvan; Hsu, Chiu-Hsieh; Chow, Hsiao-Hui; Ahnen, Dennis J.; Boland, C. Richard; Heigh, Russell I.; Fay, David E.; Martinez, Maria Elena; Jacobs, Elizabeth T; Ashbeck, Erin L.; Alberts, David S; Lance, Michael P.

In: Cancer Prevention Research, Vol. 5, No. 12, 12.2012, p. 1381-1393.

Research output: Contribution to journalArticle

Thompson, Patricia ; Roe, Denise ; Fales, Liane ; Buckmeier, Julie ; Wang, Fang ; Hamilton, Stanley R. ; Bhattacharyya, Achyut K ; Green, Sylvan ; Hsu, Chiu-Hsieh ; Chow, Hsiao-Hui ; Ahnen, Dennis J. ; Boland, C. Richard ; Heigh, Russell I. ; Fay, David E. ; Martinez, Maria Elena ; Jacobs, Elizabeth T ; Ashbeck, Erin L. ; Alberts, David S ; Lance, Michael P. / Design and baseline characteristics of participants in a phase III randomized trial of celecoxib and selenium for colorectal adenoma prevention. In: Cancer Prevention Research. 2012 ; Vol. 5, No. 12. pp. 1381-1393.
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abstract = "COX inhibitors reduce colorectal adenoma recurrence by up to 45{\%} and selenium supplementation may prevent colorectal cancer. Following colonoscopic adenoma resection, 1,600 men and women, ages 40 to 80 years, were randomized to celecoxib (400 mg daily), a selective COX-2 inhibitor, and/or selenium (200 mg daily as selenized yeast), or double placebo. The trial was initiated in November 2001. The primary trial endpoint is adenoma recurrence in each intervention group compared with placebo, as determined by surveillance colonoscopy conducted three to five years after baseline. Randomization was stratified by use of low-dose aspirin (81 mg) and clinic site. Following reports of cardiovascular toxicity associated with COX-2 inhibitors, the celecoxib arm was discontinued in December 2004 when 824 participants had been randomized. Accrual continued with randomization to selenium alone or placebo. Randomization of the originally planned cohort (n = 1,621) was completed in November 2008. A further 200 patients with one or more advanced adenomas (denoting increased risk for colorectal cancer) were accrued to enhance statistical power for determining intervention efficacy in this higher-risk subgroup. Accrual of the total cohort (n = 1,824) was completed in January 2011. Baseline cohort characteristics include: mean age 62.9 years; 65{\%} male; body mass index (BMI) 29.1 ± 5.1; 47{\%} taking low-dose aspirin while on trial; 20{\%} with three or more adenomas; and 38{\%} with advanced adenomas. Intervention effects on adenoma recurrence will be determined, and their modification by genetic background and baseline selenium level. The effect of selenium supplementation on risk for type II diabetes will also be reported.",
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AU - Wang, Fang

AU - Hamilton, Stanley R.

AU - Bhattacharyya, Achyut K

AU - Green, Sylvan

AU - Hsu, Chiu-Hsieh

AU - Chow, Hsiao-Hui

AU - Ahnen, Dennis J.

AU - Boland, C. Richard

AU - Heigh, Russell I.

AU - Fay, David E.

AU - Martinez, Maria Elena

AU - Jacobs, Elizabeth T

AU - Ashbeck, Erin L.

AU - Alberts, David S

AU - Lance, Michael P

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