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NCT Number: NCT00641147

Curcumin in Treating Patients With Familial Adenomatous Polyposis

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.

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Key information

Conditions

Familial Adenomatous Polyposis Adenoma Adenomatous Polyposis Coli Adenomatous Polyps Colonic Diseases Colorectal Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Intestinal Diseases Intestinal Neoplasms Intestinal Polyposis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Syndromes, Hereditary

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Puerto Rico, San Juan, Puerto Rico

Loading trial locations.

About this study

Specific Aims:

I. To determine in a randomized, double-blinded, placebo-controlled study the tolerability and effectiveness of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in familial adenomatous polyposis patients with intact colons, ileorectal anastomosis surgery, or ileo-anal pullthrough (reservoir) surgery.

II. To measure markers of cell proliferation including colorectal mucosal levels of ornithine decarboxylase (ODC), polyamines, mucosal deoxyribonucleic acid (DNA) methylation, proliferative index (Ki67 antiproliferative cell nuclear antibody), apoptosis index, vascular density, mucosal prostaglandin, leukotriene levels, and activation of the nuclear factor kappa B (NFKB), and v-akt murine thymoma viral oncogene homolog 1 (Akt) survival pathways.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive curcumin orally (PO) twice daily (BID) for 12 months.

Arm II: Patients receive placebo PO BID for 12 months.

After completion of study treatment, patients are followed up at 4 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) < 3500/ml
  • Platelet count < 100,000/ml
  • Blood urea nitrogen (BUN) > 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

Treatment and study plan

curcumin

Drug

Given PO

Other names: C.I. 75300, C.I. Natural Yellow 3, Diferuloylmethane, Turmeric Yellow

laboratory biomarker analysis

Other

Correlative studies

Placebo

Other

Given PO

Other names: placebo therapy, sham therapy

Primary outcomes

  1. Polyp Number

    Time frame: Up to 12 months

    Average number of polyps in the placebo arm at the end of the study is compared to the average in the curcumin arm

Secondary outcomes

  1. Mean Polyp Size in mm

    Time frame: Up to 12 months

    Mean size of the 5 largest polyps

  2. Number of Participants With a Decrease in Polyp Burden at 12 Months

    Time frame: 12 months

    The polyp burden as evaluated by video tape review. Polyp burden at 12 months compared to time 0 for each participant and counting participants with decrease in polyp burden at 12 months.

  3. Number of Participants With Grade >=2 Adverse Events

    Time frame: Up to 12 months

    Events were graded as follows:

    Grade 0= no adverse event or within normal limits; Grade 1= mild adverse event (causing no limitations of usual activity); Grade 2= moderate adverse event (causing some limitation of activity); Grade 3= severe adverse event (severe and undesirable; causing inability to carry out usual activities; Grade 4= life threatening or disabling adverse event; Grade 5= fatal adverse event.

  4. Medication Compliance

    Time frame: Up to 12 months

    Medication compliance of the participant= number of capsules taken divided by the number of capsules prescribed as determined by pill count and described as a percentage per participant. Then the compliance of each participant in the assigned group (curcumin or placebo) was averaged together to obtain the medication compliance rate of that group.

  5. Change in Ornithine Decarboxylase (ODC) Activity Levels

    Time frame: Baseline and 8 months

    Change in ODC mean activity levels (expressed as nmol of activity/mg of mucosal tissue/hr) at 8 months compared to baseline (time 0)

  6. Change in Total Polyamines Levels

    Time frame: Baseline and 8 months

    Polyamine mean level changes (expressed as pg/mg protein) at month 8-baseline

  7. Change in Micro RNA 124-U6 (miR124-U6)

    Time frame: Baseline and 8 months

    Change in MicroRNA mean activity level at 8 months compared to baseline (time 0)

  8. Change in Spermidine/Spermine N-1 Acetyl Transferase (SSAT)

    Time frame: Baseline and 8 months

    Change in SSAT mean activity level at 8 months compared to baseline (time 0)

  9. Change in Spermine Oxidase (SMOX)

    Time frame: Baseline and 8months

    Change in SMOX mean activity level at 8 months compared to baseline (time 0)

  10. Change in Ki-67 Anti-proliferative Cell Nuclear Antibody Index Levels

    Time frame: Baseline up to 8 months

    Change in cellular proliferation rate was measured by assessment of Ki-67 anti-proliferative cell nuclear antibody index levels at 8 months

  11. Change in Apoptosis Index Levels

    Time frame: 8 months

    Change in apoptosis index levels at 8 months by assessing cleaved Caspase-3 measurement

Other outcomes

  1. Change in Mucosal DNA Methylation Levels.

    Time frame: Baseline to up to 12 months

  2. Change in Mucosal Leukotriene Levels.

    Time frame: Baseline to up to 12 months.

  3. Change in Mucosal Prostaglandin Levels.

    Time frame: Baseline to up to 12 months.

  4. Number of Patients Failing Study.

    Time frame: Up to 16 months.

    Patients withdrawn from study due to increasing polyp burden and/or advancing histology.

  5. Change in Vascular Density

    Time frame: Baseline up to 12 months

  6. Activation of NFKB (Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells) Pathway

    Time frame: Baseline to 12 months

  7. Change in Akt Phosphorylation Levels

    Time frame: Baseline up to 12 months

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Mar 24, 2008
Registry last updated
Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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