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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Adenomatous Polyps

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Cellular proliferation and apoptosis in the colonic mucosa

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Carmen E Guerra, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

802193

NCT ID:

NCT00118989

Start Date:

July 2005

Completion Date:

July 2012

Related Keywords:

  • Adenomatous Polyps
  • Curcumin
  • chemoprevention
  • adenomatous polyps
  • colorectal cancer
  • Colorectal Neoplasms
  • Polyps
  • Adenomatous Polyps

Name

Location

University of PennsylvaniaPhiladelphia, Pennsylvania  19104