Curcumin for the Chemoprevention of Colorectal Cancer

NCT00118989 | Terminated

• 1 other identifier: 802193
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aims:

• To determine if curcuminoids modulate cellular proliferation as measured by proliferating cell nuclear antigen (PCNA) in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps. Hypothesis: Curcuminoids decrease cellular proliferation in the colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps.
• To determine if curcuminoids modulate apoptosis, as measured by TUNEL assay, in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps. Hypothesis: Curcuminoids increase apoptosis in colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps.
• To determine if curcuminoids modulate COX-2 expression as measured by immunohistochemical assays in subjects with previously resected adenomatous colonic polyps Hypothesis: Curcuminoids decrease colorectal mucosa COX-2 expression in subjects with previously resected sporadic adenomatous colonic polyps.
• To determine if curcuminoids modulate COX-2 activity as measured by urinary eicosanoids Hypothesis: Curcuminoids decrease concentrations of urinary eicosanoids.

Conditions

Adenomatous Polyps

Keywords

Curcumin; chemoprevention; adenomatous polyps; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Cellular proliferation and apoptosis in the colonic mucosa

  4 months

Secondary Outcomes (1)

• COX-2 expression and activity

  4 months

Study Arms (2)

PLACEBO

PLACEBO COMPARATOR

placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months

Dietary Supplement: Curcuminoids

Curcuminoids C3 Complex® to be taken orally via caps

EXPERIMENTAL

Curcuminoids C3 Complex® or placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months

Dietary Supplement: Curcuminoids

Interventions

Curcuminoids DIETARY_SUPPLEMENT

Curcuminoids C3 Complex® or placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months

Also known as: Curcuminoids C3 Complex® (Sabinsa Co.)

Curcuminoids C3 Complex® to be taken orally via caps; PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18
• A diagnosis for colon/rectal polyp resection, polypectomy
• Subjects must be able to have the capacity and must be willing to provide informed consent
• Premenopausal women must be surgically incapable of childbearing or be using a medically acceptable method of contraception (oral contraceptives, diaphragms, condoms with spermicide, IUD, progesterone injection or implant) throughout the entire length of the study
• Men should wear condoms during the duration of the study given the unknown effects of curcumin on sperm viability, fertility

You may not qualify if:

• Previous or current history of colorectal cancer
• Previous history of Familial Polyposis Syndromes
• Previous history of inflammatory bowel disease
• Previous surgery of the large bowel
• Liver disease defined as AST and ALT\>3x upper limit of normal
• Known history of gallstones, biliary colic or serum bilirubin \>2.0
• Cardiac disease including myocardial infarction, congestive heart failure, arrhythmia
• Renal disease defined as creatinine \>1.5
• Hematopoietic disease defined as WBC\<4000, platelet count \<100,000, hemoglobin\<10.0 or coagulation or bleeding disorder
• Significantly impaired gastrointestinal function or absorption
• Peptic ulcer disease
• Active infection including viral, bacterial, atypical or fungal infections of any organ system including HIV
• Previous history of allergy to turmeric, Indian curries, aspirin or NSAIDs
• Pregnant or lactating women
• Dementia or other neurologic or psychiatric disease which may impede the ability to follow the protocol

Sponsors & Collaborators

• University of Pennsylvania: lead
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Adenomatous Polyps; Colorectal Neoplasms

Interventions

Diarylheptanoids

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Carmen E Guerra, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2005
• First Posted: July 12, 2005
• Study Start: July 1, 2005
• Primary Completion: September 1, 2010
• Study Completion: July 1, 2012
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

US (1)