Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)

NCT00927485 | Completed Results DMC

• 1 other identifier: Protocol A2210108-UPR
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Familial Adenomatous Polyposis (FAP) is an autosomal dominant disorder characterized by the formation of multiple adenomatous colorectal polyps usually in the teenage years. Virtually, all patients with FAP will develop colorectal cancer on average by the 5th decade of life if prophylactic surgery is not performed. Besides, these individuals must have lifelong cancer surveillance of the remaining colorectum or ileum. Use of nonsteroidal anti-inflammatory drug (NSAID), such as sulindac, or celecoxib, which selectively inhibits prostaglandin synthesis primarily via the inhibition of cyclogenase-2 (COX-2) have been shown to reduce the incidence and induce regression of adenomas in the rectum of patients with FAP. However, use of NSAIDs and COX-2 inhibitors is associated with significant comorbidity including renal and gastric toxicity and increased risk of vascular events. Therefore, identification of a chemopreventive agent that would have similar efficacy but less toxicity would enhance our ability to treat these patients. Therefore the following specific aim has been proposed:To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients with FAP.

Conditions

Familial Adenomatous Polyposis

Keywords

Familial Adenomatous Polyposis (FAP); Curcumin; Colorectal polyps; Duodenal polyps

Outcome Measures

Primary Outcomes (2)

• Number of Polyps

  To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number in patients with FAP.

  5 years

• Size of Polyps

  To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp size in patients with FAP.

  5 years

Study Arms (2)

Curcumin

EXPERIMENTAL

Curcumin

Drug: Calcumin (Curcumin); Other: Risk Factor Questionnaire; Other: Blood samples; Other: Biopsies (Sigmoidoscopy); Other: Biopsies (Upper endoscopy)

Placebo

PLACEBO COMPARATOR

Placebo (sugar pills)

Drug: Calcumin (Curcumin); Other: Risk Factor Questionnaire; Other: Blood samples; Other: Biopsies (Sigmoidoscopy); Other: Biopsies (Upper endoscopy)

Interventions

Calcumin (Curcumin) DRUG

Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Also known as: Curcumin

Curcumin; Placebo

Risk Factor Questionnaire OTHER

Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Curcumin; Placebo

Blood samples OTHER

Three tubes of blood at visits 0, 4 and 12 months.

Curcumin; Placebo

Biopsies (Sigmoidoscopy) OTHER

Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.

Curcumin; Placebo

Biopsies (Upper endoscopy) OTHER

Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Curcumin; Placebo

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years with FAP (with an intact colon or who have had surgery)

You may not qualify if:

• Mentally incompetent
• Female patients of childbearing age not on effective birth control
• Patients with WBC \< 3,500/ml, platelet count \< 100,000/ml, BUN \> 25mg%, creatinine \> 1.5mg%
• Patients unable to stop NSAIDS or aspirin use for the duration of the study
• Malignancy other than nonmelanoma skin cancer
• Active bacterial infection
• Patients with GERD (Gastro esophageal reflux disease)
• Patients with a history of peptic (stomach or duodenal) ulcer disease
• Patients on Warfarin or anti-platelet drugs

Sponsors & Collaborators

• University of Puerto Rico: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Puerto Rico Comprehensive Cancer Center

San Juan, 00936, Puerto Rico

Location

Related Publications (1)

• Cruz-Correa M, Hylind LM, Marrero JH, Zahurak ML, Murray-Stewart T, Casero RA Jr, Montgomery EA, Iacobuzio-Donahue C, Brosens LA, Offerhaus GJ, Umar A, Rodriguez LM, Giardiello FM. Efficacy and Safety of Curcumin in Treatment of Intestinal Adenomas in Patients With Familial Adenomatous Polyposis. Gastroenterology. 2018 Sep;155(3):668-673. doi: 10.1053/j.gastro.2018.05.031. Epub 2018 May 23.

  PMID: 29802852 RESULT

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Interventions

Curcumin; Blood Specimen Collection; Biopsy; Sigmoidoscopy; Gastroscopy

Condition Hierarchy (Ancestors)

Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Colonoscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Dr. Marcia Cruz-Correa
• Organization: University of Puerto Rico Medical Sciences Campus

marcia.cruz1@upr.edu

787-758-2525

Study Officials

• Marcia R. Cruz-Correa, MD. PhD

  University of Puerto Rico Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastrointestinal Oncology

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 25, 2009
• Study Start: November 1, 2007
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 16, 2020
• Results First Posted: December 16, 2020

Record last verified: 2020-11

Locations

PR (1)