Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis Patients

This study has been withdrawn prior to enrollment.
(Subsequent data generated by our collaborators have shown efficacy with curcumin and quercetin in 5 patients in a non placebo controlled trial.)
Sponsor:
Information provided by (Responsible Party):
Francis M. Giardiello, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00248053
First received: November 1, 2005
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to assess if curcumin, a commonly used food spice, can regress colorectal adenomatous polyps in patients with familial adenomatous polyposis, an inherited form of colorectal cancer.


Condition Intervention Phase
Familial Adenomatous Polyposis
Drug: curcumin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis (FAP) Patients

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • polyp number and size [ Time Frame: one year ]

Secondary Outcome Measures:
  • side effects and medication compliance [ Time Frame: one year ]

Enrollment: 0
Study Start Date: November 2005
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lower GI Drug: curcumin
curcumin 500 mg by mouth, three times a day for 9 months

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Familial adenomatous polyposis
  • 18 years of age or older
  • 5 or more adenomas of colorectum or ileum

Exclusion Criteria:

  • Female patient of child bearing age not on effective birth control pills
  • Pregnant women
  • White blood cell (WBC) count less than 4000
  • Platelets (Plts) less than 100,000
  • Blood urea nitrogen (BUN) greater than 25
  • Creatine greater than 1.5
  • Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs) during duration of trial
  • Malignancy
  • Patient with active bacterial infections of gastroesophageal reflux disease or peptic ulcer disease
  • Patient on warfarin or anti-platelet drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248053

Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Francis M Giardiello, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Francis M. Giardiello, Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00248053     History of Changes
Other Study ID Numbers: 05-04-12-04
Study First Received: November 1, 2005
Last Updated: September 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Familial adenomatous polyposis patient with 5 or more adenomatous polyps in the colon or ileoanal pouch

Additional relevant MeSH terms:
Adenomatous Polyposis Coli
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Intestinal Polyposis
Genetic Diseases, Inborn
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal

ClinicalTrials.gov processed this record on August 21, 2014