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Curcumin Biomarkers

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University of North Carolina, Chapel Hill

キーワード

概要

Colorectal cancer is a major problem in the United States and other developed countries. A safe and effective chemopreventive agent could reduce the burden of colorectal neoplasia. Curcumin, is a product that is derived from Curcuma longa. It has been used for thousands of years as a traditional remedy. Curcumin blocks a number of targets involved in tumor initiation, promotion, and progression, and is considered a promising chemopreventive agent. The investigators propose to enroll 40 patients after screening colonoscopy who will have rectal biopsies at baseline and after 4 weeks of curcumin 4 grams per day. The investigators will use microarray analysis to identify genes that are modified by curcumin that could be used as biomarkers in future chemoprevention studies. The study will also evaluate tolerability and toxicity.

日付

最終確認済み: 12/31/2012
最初に提出された: 04/05/2011
提出された推定登録数: 04/10/2011
最初の投稿: 04/11/2011
最終更新が送信されました: 02/05/2013
最終更新日: 02/06/2013
実際の研究開始日: 10/31/2010
一次完了予定日: 09/30/2011
研究完了予定日: 12/31/2012

状態または病気

Colorectal Cancer

介入/治療

Drug: Curcumin

段階

段階 1

アームグループ

介入/治療
Experimental: Curcumin
4g Curcumin C3 tablet daily
Drug: Curcumin
4 grams Curcumin C3 tablet daily x30 days

適格基準

研究の対象となる年齢 40 Years に 40 Years
研究に適格な性別All
健康なボランティアを受け入れるはい
基準

Inclusion Criteria:

1. Age 40 - 80.

2. A willingness to follow the study protocol, as indicated by provision of informed consent to participate

3. Good general health

Exclusion Criteria:

1. Familial colorectal cancer syndromes (e.g. Hereditary Non-Polyposis Colon Cancer, Familial Adenomatous Polyposis)

2. Ulcerative colitis or Crohn's disease.

3. History of large bowel resection for any reason

4. Diagnosed narcotic or alcohol dependence

5. Unwillingness to forgo curcumin/turmeric-containing supplements during the trial or consumption of curry/turmeric at meals > 3 times a week.

6. Allergy to turmeric/curcumin.

7. Women with childbearing potential who do not agree to practice effective birth control.

8. Individuals with creatinine, AST or ALT above 1.5 times the upper limit of normal at baseline.

9. Personal or inherited bleeding disorders or therapeutic anti-coagulation with warfarin.

10. Women who are pregnant or nursing.

11. Individuals who have taken antibiotics within the three months prior to enrollment.

結果

主な結果の測定

1. Gene expression [30 days]

Change in gene expression

2. Ribonucleic acid (RNA) level [30 days]

Transcript level as mRNA copies per cell

3. Apoptosis [30 days]

Immunohistochemistry (IHC) signal as intensity and proportion of cells stained

二次的な結果の測定

1. Number of Participants with Adverse Events [30 days]

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