Curcumin in Treating Patients With Familial Adenomatous Polyposis

NCT00641147 | Completed Phase 2 Results DMC

• 6 other identifiers: NCI-2013-00536CDR0000592794NA_000118211R01CA134620R01CA134620P30CA006973
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 2

Brief Summary

This randomized phase II trial studies curcumin in treating patients with familial adenomatous polyposis. Curcumin may prevent colorectal cancer in patients with a history of rectal polyps or colorectal neoplasia.

Conditions

Familial Adenomatous Polyposis

Outcome Measures

Primary Outcomes (1)

• Polyp Number

  Average number of polyps in the placebo arm at the end of the study is compared to the average in the curcumin arm

  Up to 12 months

Secondary Outcomes (11)

• Mean Polyp Size in mm

  Up to 12 months

• Number of Participants With a Decrease in Polyp Burden at 12 Months

  12 months

• Number of Participants With Grade >=2 Adverse Events

  Up to 12 months

• Medication Compliance

  Up to 12 months

• Change in Ornithine Decarboxylase (ODC) Activity Levels

  Baseline and 8 months

Other Outcomes (7)

• Change in Mucosal DNA Methylation Levels.

  Baseline to up to 12 months

• Change in Mucosal Leukotriene Levels.

  Baseline to up to 12 months.

• Change in Mucosal Prostaglandin Levels.

  Baseline to up to 12 months.

Study Arms (2)

Arm I (curcumin)

EXPERIMENTAL

Patients receive curcumin PO BID for 12 months. Laboratory Biomarker Analysis

Drug: Curcumin; Other: Laboratory Biomarker Analysis

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO BID for 12 months. Laboratory Biomarker Analysis

Other: Laboratory Biomarker Analysis; Other: Placebo

Interventions

Curcumin DRUG

Given PO

Also known as: C.I. 75300, C.I. Natural Yellow 3, Diferuloylmethane, Turmeric Yellow

Arm I (curcumin)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (curcumin); Arm II (placebo)

Placebo OTHER

Given PO

Also known as: placebo therapy, sham therapy

Arm II (placebo)

Eligibility Criteria

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

You may qualify if:

• Patients with familial adenomatous polyposis who have undergone subtotal colectomy with ileorectal anastomosis, total colectomy with ileo-anal pull through (reservoir), and patients with intact colons with 5 or more adenomas in the rectum-sigmoid or reservoir
• Patients with familial adenomatous polyposis (FAP) and duodenal adenomatous polyposis without current lower tract adenomatous polyposis i.e. status/post (s/p) ileostomy

You may not qualify if:

• Female patients of childbearing age not on effective birth control
• Pregnant women
• White blood cell count (WBC) \< 3500/ml
• Platelet count \< 100,000/ml
• Blood urea nitrogen (BUN) \> 25mg%
• Creatinine \> 1.5mg%
• Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, curcumin, tumeric, calcium, vitamin D, green tea, or polyphenol E supplements for the duration of the trial
• Malignancy other than nonmelanoma skin cancer
• Active bacterial infection
• Patients with symptoms of active gastroesophageal reflux disease (GERD) (symptomatic despite medication or current erosive esophagitis on endoscopy)
• Patients with a history of peptic ulcer disease
• Patients on warfarin or plavix

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

University of Puerto Rico

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 DERIVED

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Interventions

Curcumin

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

Results Point of Contact

• Title: Study Coordinator
• Organization: Johns Hopkins University

lhylind1@jhmi.edu

410-955-3817

Study Officials

• Francis Giardiello

  Johns Hopkins University/Sidney Kimmel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 24, 2008
• Study Start: October 1, 2010
• Primary Completion: November 1, 2016
• Study Completion: November 30, 2016
• Last Updated: September 29, 2017
• Results First Posted: September 29, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (1)