- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00248053
Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis Patients
September 18, 2012 updated by: Francis M. Giardiello, Johns Hopkins University
Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis (FAP) Patients
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.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Lower GI
|
curcumin 500 mg by mouth, three times a day for 9 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
polyp number and size
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
side effects and medication compliance
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Francis M Giardiello, M.D., Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
November 1, 2005
First Submitted That Met QC Criteria
November 1, 2005
First Posted (Estimate)
November 3, 2005
Study Record Updates
Last Update Posted (Estimate)
September 20, 2012
Last Update Submitted That Met QC Criteria
September 18, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genetic Diseases, Inborn
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Syndromes, Hereditary
- Adenomatous Polyps
- Adenoma
- Intestinal Polyposis
- Nasopharyngeal Neoplasms
- Colorectal Neoplasms
- Adenomatous Polyposis Coli
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- 05-04-12-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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M.D. Anderson Cancer CenterCompletedAttenuated Familial Adenomatous Polyposis | Deleterious Familial Adenomatous PolyposisUnited States
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