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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000559650 | Registry Identifier | PDQ (Physician Data Query) | |
| BWH-94-06819 | Other Identifier | Brigham and Women's Hospital Legacy # | |
| R01CA067883 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Dana-Farber/Brigham and Women's Cancer Center | OTHER |
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RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming. The use of folic acid may prevent colorectal cancer.
PURPOSE: This randomized clinical trial is studying how well folic acid works compared with a placebo in preventing colorectal polyps in patients who have had previous colorectal polyps.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Folic acid | Other | Folic acid supplement 1g/day |
|
| Placebo | Other | Placebo pill once per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folic acid | Dietary Supplement | Intervention group 1g folic acid per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent colorectal adenoma | May 1996-March 2004 |
| Measure | Description | Time Frame |
|---|---|---|
| recurrent adenoma by location, size, stage, number, | May1996-March 2004 |
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DISEASE CHARACTERISTICS:
Inclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward L. Giovannucci, MD, ScD | Dana-Farber/Brigham and Women's Cancer Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19864409 | Result | Wu K, Platz EA, Willett WC, Fuchs CS, Selhub J, Rosner BA, Hunter DJ, Giovannucci E. A randomized trial on folic acid supplementation and risk of recurrent colorectal adenoma. Am J Clin Nutr. 2009 Dec;90(6):1623-31. doi: 10.3945/ajcn.2009.28319. Epub 2009 Oct 28. | |
| 21170989 | Result | Figueiredo JC, Mott LA, Giovannucci E, Wu K, Cole B, Grainge MJ, Logan RF, Baron JA. Folic acid and prevention of colorectal adenomas: a combined analysis of randomized clinical trials. Int J Cancer. 2011 Jul 1;129(1):192-203. doi: 10.1002/ijc.25872. Epub 2011 Apr 1. |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo |
| Other |
One placebo pill per day |
|
| D006571 | Heterocyclic Compounds |