Phase 2 N=44 Randomized Double-blind Treatment

Curcumin in Treating Patients With Familial Adenomatous Polyposis

Familial Adenomatous Polyposis

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View on ClinicalTrials.gov: NCT00641147 ↗

Enrolled (actual)

Serious AEs

9.1%

Results posted

Sep 2017

Primary outcome: Primary: Polyp Number — 22.6; 18.6 polyps — p=0.58

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Curcumin (Drug); Laboratory Biomarker Analysis (Other); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Polyp Number	22.6; 18.6	0.58
SECONDARY Mean Polyp Size in mm	2.3; 2.1	0.76
SECONDARY Number of Participants With a Decrease in Polyp Burden at 12 Months	4; 6	0.85
SECONDARY Number of Participants With Grade >=2 Adverse Events	6; 2	0.16
SECONDARY Medication Compliance	0.83; 0.91	0.31
SECONDARY Change in Ornithine Decarboxylase (ODC) Activity Levels	1.19; 0.88	0.63
SECONDARY Change in Total Polyamines Levels	0.23; 1.66	0.24
SECONDARY Change in Micro RNA 124-U6 (miR124-U6)	1.44; 4.88	0.63
SECONDARY Change in Spermidine/Spermine N-1 Acetyl Transferase (SSAT)	0.97; 0.99	0.93
SECONDARY Change in Spermine Oxidase (SMOX)	1.20; 1.56	0.41
SECONDARY Change in Ki-67 Anti-proliferative Cell Nuclear Antibody Index Levels	0.47; 0.41	0.14
SECONDARY Change in Apoptosis Index Levels	0.57; 2.44	0.09

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Female patients of childbearing age not on effective birth control
Pregnant women
White blood cell count (WBC) 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00641147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.