Sulindac and Plant Compounds in Preventing Colon Cancer

Sponsor
University of Medicine and Dentistry of New Jersey (Other)
Overall Status
Terminated
CT.gov ID
NCT00003365
Collaborator
National Cancer Institute (NCI) (NIH)
1
119

Study Details

Study Description

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
N/A

Detailed Description

OBJECTIVES:
  • 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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Primary Purpose:
Prevention
Official Title:
The Effect of Plant Phenolic Compounds on Human Colon Epithelial Cells
Study Start Date :
Aug 1, 1996
Actual Primary Completion Date :
Jul 1, 2006
Actual Study Completion Date :
Jul 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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:

    • 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

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • Not specified
    Life expectancy:
    • Not specified
    Hematopoietic:
    • 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

    Hepatic:
    • No liver disease
    Renal:
    • No renal insufficiency
    Cardiovascular:
    • 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

    Other:
    • 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

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • Not specified
    Chemotherapy:
    • Not specified
    Endocrine therapy:
    • Not specified
    Radiotherapy:
    • Not specified
    Surgery:
    • Not specified
    Other:
    • 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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)

    Investigators

    • Study Chair: Steven J. Shiff, MD, Rutgers Cancer Institute of New Jersey

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00003365
    Other Study ID Numbers:
    • CDR0000066350
    • P30CA016056
    • RUH-SSH-190-0600
    • RUH-SSH-190-0698
    • NCI-V98-1425
    First Posted:
    May 21, 2004
    Last Update Posted:
    Jan 27, 2011
    Last Verified:
    Jan 1, 2011
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 27, 2011