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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 |
Dietary Supplement: curcumin Dietary Supplement: rutin Drug: quercetin 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.
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: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003365 History of Changes |
Health Authority: | United States: Federal Government |
colon cancer |
Anti-Inflammatory Agents Digestive System Neoplasms Curcumin Antioxidants Gastrointestinal Diseases Cyclooxygenase Inhibitors Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Digestive System Diseases Analgesics, Non-Narcotic Gastrointestinal Neoplasms Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Sulindac Antirheumatic Agents Quercetin Colorectal Neoplasms |
Anti-Inflammatory Agents Antioxidants Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Rectal Diseases Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Digestive System Neoplasms Cyclooxygenase Inhibitors |
Enzyme Inhibitors Intestinal Diseases Protective Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Analgesics, Non-Narcotic Gastrointestinal Neoplasms Peripheral Nervous System Agents Sulindac Antirheumatic Agents Central Nervous System Agents Quercetin Colorectal Neoplasms |