Clinical trial · Interventional
Curcumin for the Chemoprevention of Colorectal Cancer
Phase II Double Blind Placebo-Controlled Trial of Curcuminoids' Effect on Cellular Proliferation, Apoptosis and COX-2 Expression in the Colorectal Mucosa of Subjects With Recently Resected Sporadic Adenomatous Polyps
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Could not be completed due to technology problems and cost constraints
Summary
Brief summary (as posted)
Specific Aims: * To determine if curcuminoids modulate cellular proliferation as measured by proliferating cell nuclear antigen (PCNA) in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps. Hypothesis: Curcuminoids decrease cellular proliferation in the colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps. * To determine if curcuminoids modulate apoptosis, as measured by TUNEL assay, in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps. Hypothesis: Curcuminoids increase apoptosis in colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps. * To determine if curcuminoids modulate COX-2 expression as measured by immunohistochemical assays in subjects with previously resected adenomatous colonic polyps Hypothesis: Curcuminoids decrease colorectal mucosa COX-2 expression in subjects with previously resected sporadic adenomatous colonic polyps. * To determine if curcuminoids modulate COX-2 activity as measured by urinary eicosanoids Hypothesis: Curcuminoids decrease concentrations of urinary eicosanoids.
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 |
|---|---|---|---|
| Adenomatous Polyps | Adenomatous Polyp | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Curcuminoids | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- PLACEBO
- description
- placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months
- interventionNames
- Dietary Supplement: Curcuminoids
- type
- EXPERIMENTAL
- label
- Curcuminoids C3 Complex® to be taken orally via caps
- description
- Curcuminoids C3 Complex® or placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months
- interventionNames
- Dietary Supplement: Curcuminoids
Primary outcomes (1)
- measure
- Cellular proliferation and apoptosis in the colonic mucosa
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age\>18 * A diagnosis for colon/rectal polyp resection, polypectomy * Subjects must be able to have the capacity and must be willing to provide informed consent * Premenopausal women must be surgically incapable of childbearing or be using a medically acceptable method of contraception (oral contraceptives, diaphragms, condoms with spermicide, IUD, progesterone injection or implant) throughout the entire length of the study * Men should wear condoms during the duration of the study given the unknown effects of curcumin on sperm viability, fertility Exclusion Criteria: * Previous or current history of colorectal cancer * Previous history of Familial Polyposis Syndromes * Previous history of inflammatory bowel disease * Previous surgery of the large bowel * Liver disease defined as AST and ALT\>3x upper limit of normal * Known history of gallstones, biliary colic or serum bilirubin \>2.0 * Cardiac disease including myocardial infarction, congestive heart failure, arrhythmia * Renal disease defined as creatinine \>1.5 * Hematopoietic disease defined as WBC\<4000, platelet count \<100,000, hemoglobin\<10.0 or coagulation or bleeding disorder * Significantly impaired gastrointestinal function or absorption * Peptic ulcer disease * Active infection including viral, bacterial, atypical or fungal infections of any organ system including HIV * Previous history of allergy to turmeric, Indian curries, aspirin or NSAIDs * Pregnant or lactating women * Dementia or other neurologic or psychiatric disease which may impede the ability to follow the protocol * Inability to swallow pills * Prior or concurrent therapy with any herbal or dietary supplement containing curcuminoids * Concurrent use of anticoagulants or antiplatelets including warfarin, clopidogrel * Prior or concurrent use of colorectal cancer chemopreventive agents including herbals: Sulindac or other NSAIDs, aspirin, COX-2 inhibitors, 5-aminosalicylate, folate, calcium, or their use within 14 days of enrollment * Concurrent use of immunosuppressants
References
Publications (0)
Data not yet available