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Sponsored by: |
Rockefeller University |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003365 |
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of sulindac may be an effective way to prevent colon cancer. Eating a diet rich in fruits and vegetables appears to reduce the risk of some types of cancer. Curcumin, rutin, and quercetin are compounds found in plants that may prevent the development of colon cancer.
PURPOSE: Randomized clinical trial to study the effectiveness of sulindac, curcumin, rutin, and quercetin in preventing colon cancer.
Condition | Intervention |
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Colorectal Cancer |
Drug: curcumin Drug: quercetin Drug: rutin Drug: sulindac |
Study Type: | Interventional |
Study Design: | Prevention, Randomized |
Official Title: | The Effect of Plant Phenolic Compounds on Human Colon Epithelial Cells |
Study Start Date: | August 1996 |
OBJECTIVES:
OUTLINE: This is a randomized, controlled, two part, single institution study. Patients in Part B are randomized by gender.
All patients undergo flexible sigmoidoscopic exam.
Patients are followed every 2 weeks.
PROJECTED ACCRUAL: There will be 130 patients (110 in Part A and 20 in Part B) accrued into this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Individuals at average risk (Parts A and B) or above average risk (Part A only) for development of colon cancer
Average risk individuals defined as:
Above average risk individuals defined as:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |
Rockefeller University Hospital | |
New York, New York, United States, 10021-6399 |
Study Chair: | Steven J. Shiff, MD | Cancer Institute of New Jersey |
Study ID Numbers: | CDR0000066350, RUH-SSH-190-0600, RUH-SSH-190-0698, NCI-V98-1425 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003365 |
Health Authority: | United States: Federal Government |
colon cancer |
Curcumin Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms |
Sulindac Intestinal Diseases Quercetin Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Anti-Inflammatory Agents Antioxidants Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Protective Agents Pharmacologic Actions Neoplasms |
Neoplasms by Site Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |