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Curcumin in Treating Patients With Familial Adenomatous Polyposis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00641147
Recruitment Status : Completed
First Posted : March 24, 2008
Results First Posted : September 29, 2017
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Familial Adenomatous Polyposis Drug: Curcumin Other: Laboratory Biomarker Analysis Other: Placebo Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
Study Start Date : October 2010
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues
Drug Information available for: Curcumin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (curcumin)
Patients receive curcumin PO BID for 12 months. Laboratory Biomarker Analysis
 Drug: Curcumin
Given PO
Other Names:
  • C.I. 75300
  • C.I. Natural Yellow 3
  • Diferuloylmethane
  • Turmeric Yellow

Other: Laboratory Biomarker Analysis
Correlative studies
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO BID for 12 months. Laboratory Biomarker Analysis
 Other: Laboratory Biomarker Analysis
Correlative studies

Other: Placebo
Given PO
Other Names:
  • placebo therapy
  • sham therapy


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) < 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00641147


Locations
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United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Puerto Rico
University of Puerto Rico
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Francis Giardiello Johns Hopkins University/Sidney Kimmel Cancer Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00641147    
Other Study ID Numbers: NCI-2013-00536
NCI-2013-00536 ( Other Identifier: NCI )
CDR0000592794 ( Other Identifier: Clinical Trial Reporting Program )
NA_00011821 ( Other Identifier: Johns Hopkins University IRB )
1R01CA134620 ( U.S. NIH Grant/Contract )
R01CA134620 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
First Posted: March 24, 2008    Key Record Dates
Results First Posted: September 29, 2017
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Nasopharyngeal Neoplasms
Adenomatous Polyposis Coli
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
 Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic