Clinical trial · Interventional
Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Familial Adenomatous Polyposis (FAP) is an autosomal dominant disorder characterized by the formation of multiple adenomatous colorectal polyps usually in the teenage years. Virtually, all patients with FAP will develop colorectal cancer on average by the 5th decade of life if prophylactic surgery is not performed. Besides, these individuals must have lifelong cancer surveillance of the remaining colorectum or ileum. Use of nonsteroidal anti-inflammatory drug (NSAID), such as sulindac, or celecoxib, which selectively inhibits prostaglandin synthesis primarily via the inhibition of cyclogenase-2 (COX-2) have been shown to reduce the incidence and induce regression of adenomas in the rectum of patients with FAP. However, use of NSAIDs and COX-2 inhibitors is associated with significant comorbidity including renal and gastric toxicity and increased risk of vascular events. Therefore, identification of a chemopreventive agent that would have similar efficacy but less toxicity would enhance our ability to treat these patients. Therefore the following specific aim has been proposed:To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients with FAP.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Familial Adenomatous Polyposis | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsies (Sigmoidoscopy) | Other | — | UNRESOLVED |
| Biopsies (Upper endoscopy) | Other | — | UNRESOLVED |
| Blood samples | Other | — | UNRESOLVED |
| Calcumin (Curcumin) | Drug | — | UNRESOLVED |
| Risk Factor Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Curcumin
- description
- Curcumin
- interventionNames
- Drug: Calcumin (Curcumin)
- Other: Risk Factor Questionnaire
- Other: Blood samples
- Other: Biopsies (Sigmoidoscopy)
- Other: Biopsies (Upper endoscopy)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo (sugar pills)
- interventionNames
- Drug: Calcumin (Curcumin)
- Other: Risk Factor Questionnaire
- Other: Blood samples
- Other: Biopsies (Sigmoidoscopy)
- Other: Biopsies (Upper endoscopy)
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * 21-85 years with FAP (with an intact colon or who have had surgery) Exclusion Criteria: * Mentally incompetent * Female patients of childbearing age not on effective birth control * Patients with WBC \< 3,500/ml, platelet count \< 100,000/ml, BUN \> 25mg%, creatinine \> 1.5mg% * Patients unable to stop NSAIDS or aspirin use for the duration of the study * Malignancy other than nonmelanoma skin cancer * Active bacterial infection * Patients with GERD (Gastro esophageal reflux disease) * Patients with a history of peptic (stomach or duodenal) ulcer disease * Patients on Warfarin or anti-platelet drugs
References
Publications (1)
- RESULTCruz-Correa M, Hylind LM, Marrero JH, Zahurak ML, Murray-Stewart T, Casero RA Jr, Montgomery EA, Iacobuzio-Donahue C, Brosens LA, Offerhaus GJ, Umar A, Rodriguez LM, Giardiello FM. Efficacy and Safety of Curcumin in Treatment of Intestinal Adenomas in Patients With Familial Adenomatous Polyposis. Gastroenterology. 2018 Sep;155(3):668-673. doi: 10.1053/j.gastro.2018.05.031. Epub 2018 May 23. PMID 29802852