Curcumin for the Prevention of Colon Cancer

NCT00027495 | Completed Phase 1 DMC

• 4 other identifiers: CDR0000067916P30CA046592CCUM-9941NCI-P00-0144
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Curcumin may be effective in preventing the development of colon cancer. PURPOSE: Phase I trial to determine the dose amount of curcumin that can be tolerated to help in preventing colon cancer in healthy men and women.

Conditions

Colorectal Cancer

Keywords

colon cancer

Interventions

curcumin DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Healthy men and women age 18 and over PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * WBC greater than 4,000/mm3 * Hemoglobin greater than 12 g/dL * Platelet count greater than 120,000/mm3 Hepatic: * ALT/AST less than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase less than 1.5 times ULN * Bilirubin less than 1.5 mg/dL Renal: * Creatinine less than 1.7 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior cancer except surgically resected basal cell or squamous cell skin cancer * No history of peptic ulcer disease, gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin secreting tumors * No history of unreliability or noncompliance (missing pretreatment appointment more than twice) PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * At least 14 days since prior steroids Radiotherapy: * Not specified Surgery: * Not specified Other: * At least 14 days since prior curcumin (turmeric) rich foods * At least 14 days since prior nonsteroidal antiinflammatory drugs (NSAIDs) * No chronic medications (i.e., daily for more than 28 days) except for oral contraceptives * No concurrent coumadin or other anticoagulants

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0930, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Dean E. Brenner, MD

  University of Michigan Rogel Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: PREVENTION
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2001
• First Posted: January 27, 2003
• Study Start: December 1, 2001
• Primary Completion: February 1, 2004
• Study Completion: September 1, 2007
• Last Updated: December 21, 2012

Record last verified: 2012-12

Locations

US (1)