Phase 2
Completed N=44
Curcumin in Treating Patients With Familial Adenomatous Polyposis
Source: ClinicalTrials.gov NCT00641147 ↗Enrolled (actual)
44
Serious AEs
9.1%
Results posted
Sep 2017
Primary outcomePrimary: Polyp Number — 22.6; 18.6 polyps — p=0.58
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.
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 |
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
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. Informational only — not medical advice.