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Sulindac and Plant Compounds in Preventing Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003365
Recruitment Status : Terminated (Study completed)
First Posted : May 21, 2004
Last Update Posted : January 27, 2011
National Cancer Institute (NCI)
Information provided by:
Rutgers, The State University of New Jersey

Brief Summary:

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 or disease Intervention/treatment Phase
Colorectal Cancer Dietary Supplement: curcumin Dietary Supplement: rutin Drug: quercetin Drug: sulindac Not Applicable

Detailed Description:


  • Determine the response of the colonic epithelium in normal volunteers at average or above average risk of colon cancer, when given short term treatment with plant phenolics such as curcumin, rutin, and quercetin.
  • Compare the colonic mucosal response to the plant phenolics with their response to sulindac in order to evaluate whether they share common mechanisms for colon cancer chemoprevention.
  • Determine the lowest optimal dose for each of the three plant phenolics that is effective in modulating biomarkers of colon epithelial cell turnover and, therefore, potentially inhibiting colon cancer development.
  • Assess the response of the colonic epithelium to curcumin in volunteers at average risk of colon cancer development.

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.

  • Part A: Patients, in cohorts of 5-10, receive one of the following five treatments in addition to the control diet: nothing (arm I), oral sulindac twice a day (arm II), oral rutin at 1 of 3 doses twice a day (arms III, IV, and V), oral quercetin at 1 of 3 doses twice a day (arms V, VI, and VII), or at 1 of 3 doses oral curcumin twice a day (arms VIII, IX, and X). Patients are first randomized to the highest doses of rutin, quercetin, and curcumin and then lower doses may be given in order to determine the minimally effective dose. Treatment is continued for 6-10 weeks.
  • Part B: Patients are randomized to receive the control diet only (arm I) or the control diet plus oral curcumin twice a day (arm II) for 6-10 weeks.

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Prevention
Official Title: The Effect of Plant Phenolic Compounds on Human Colon Epithelial Cells
Study Start Date : August 1996
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Sulindac

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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:

      • No history of colon adenomas
      • No strong family history of colon polyps or cancer
    • Above average risk individuals defined as:

      • History of one or more sporadic adenomatous polyps at least 0.5 cm in size (either tubular, tubulovillous, or villous adenomas)
      • Have had polypectomy or refused this procedure
      • No significant family history of adenomatous polyps, colon cancer, or hereditary nonpolyposis colorectal cancer or other hereditary colon cancer syndrome
      • Polyps should not have had a focus of adenocarcinoma within them
  • No history of gastrointestinal cancer outside of the large bowel
  • No other gastrointestinal mucosal epithelial disease (e.g., Barrett's esophagus, chronic or recurrent peptic ulcer disease, celiac sprue, or other disorders of nutrient absorption)
  • No significant asymptomatic lesions on flexible sigmoidoscopy, such as inflammation, premalignancy or malignancy



  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • No platelet or coagulation abnormalities
  • No personal or family history of a bleeding disorder
  • Hematopoietic concentration must not be due to significant acute or chronic disorder


  • No liver disease


  • No renal insufficiency


  • No uncontrolled hypertension
  • No chronic congestive heart failure
  • No history of endocarditis
  • No history of rheumatic fever
  • No cardiac valve prostheses
  • No mitral valve prolapse that requires antibiotic prophylaxis


  • HIV negative
  • No gout
  • No pancreatitis
  • No other chronic viral infection
  • No significant acute or uncontrolled chronic medical illness
  • Generally non-smoking (no more than 4 cigarettes per week, i.e., not daily smokers)
  • Must abstain from smoking for at least 1 month prior to enrolling in the study
  • No alcohol consumption of greater than 2 glasses of wine or beer per day
  • Normal weight (90-120% of optimum body weight) and body habitus
  • No change in weight within 5-10% of body weight within the past year
  • No history of inflammatory bowel disease (either ulcerative colitis or Crohn's disease )
  • No hearing or equilibrium disorders
  • No other prior malignancy except resected carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No allergies to sulindac or tartrazine dyes or prior severe adverse reactions to nonsteroidal antiinflammatory drugs (asthma, gastrointestinal bleeding, or renal insufficiency)
  • No potential allergy to curcumin, quercetin, or rutin
  • No gastrointestinal bleeding
  • Not institutionalized, mentally disabled, or incarcerated
  • No unusually high intake of stored micronutrients or high doses of supplemental calcium or folate
  • Not pregnant or nursing


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • No concurrent coumadin
  • No chronic use of nonsteroidal antiinflammatory drugs (unless they can be stopped for 3 months)
  • No other putative colon cancer chemoprevention agents (unless they can be stopped for 3 months)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003365

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United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021-6399
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
National Cancer Institute (NCI)
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Study Chair: Steven J. Shiff, MD Rutgers Cancer Institute of New Jersey
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Responsible Party: Stephen Shiff, UMDNJ Identifier: NCT00003365    
Other Study ID Numbers: CDR0000066350
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: May 21, 2004    Key Record Dates
Last Update Posted: January 27, 2011
Last Verified: January 2011
Keywords provided by Rutgers, The State University of New Jersey:
colon cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Cyclooxygenase Inhibitors