Curcumin in Treating Patients With Familial Adenomatous Polyposis
Completed · Phase 2 · Has a placebo group
Conditions studied: Familial Adenomatous Polyposis
In brief
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.
Key facts
- Study ID
- NCT00641147
- Run by
- National Cancer Institute (NCI)
- People needed
- 44
- Starts
- 2010-10-01
- Expected to finish
- 2016-11-30
- Last updated by the study team
- 2017-09-29
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
- University of Puerto Rico — San Juan, Puerto Rico
Full record on ClinicalTrials.gov
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