The Effect of Plant Phenolic Compounds on Human Colon Epithelial Cells
18 Years
N/A
Both
Colorectal Cancer
Trial Information
The Effect of Plant Phenolic Compounds on Human Colon Epithelial Cells
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.
Inclusion Criteria
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Prevention
Principal Investigator
Steven J. Shiff, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Cancer Institute of New Jersey
Authority:
United States: Federal Government
Study ID:
CDR0000066350
NCT ID:
NCT00003365
Start Date:
August 1996
Completion Date:
July 2006
Related Keywords:
- Colorectal Cancer
- colon cancer
- Colonic Neoplasms
- Colorectal Neoplasms
Name | Location |
|---|---|
| Rockefeller University Hospital | New York, New York 10021-6399 |
