NCT00248053

Brief Summary

The purpose of this study is to assess if curcumin, a commonly used food spice, can regress colorectal adenomatous polyps in patients with familial adenomatous polyposis, an inherited form of colorectal cancer.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2005

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Last Updated

September 20, 2012

Status Verified

September 1, 2012

Enrollment Period

2.6 years

First QC Date

November 1, 2005

Last Update Submit

September 18, 2012

Conditions

Familial Adenomatous Polyposis

Keywords

Familial adenomatous polyposis patient with 5 or more adenomatous polyps in the colon or ileoanal pouch

Outcome Measures

Primary Outcomes (1)

  • polyp number and size

    one year

Secondary Outcomes (1)

  • side effects and medication compliance

    one year

Study Arms (1)

Lower GI

OTHER
Drug: curcumin

Interventions

curcuminDRUG

curcumin 500 mg by mouth, three times a day for 9 months

Lower GI

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Familial adenomatous polyposis
  • years of age or older
  • or more adenomas of colorectum or ileum

You may not qualify if:

  • Female patient of child bearing age not on effective birth control pills
  • Pregnant women
  • White blood cell (WBC) count less than 4000
  • Platelets (Plts) less than 100,000
  • Blood urea nitrogen (BUN) greater than 25
  • Creatine greater than 1.5
  • Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs) during duration of trial
  • Malignancy
  • Patient with active bacterial infections of gastroesophageal reflux disease or peptic ulcer disease
  • Patient on warfarin or anti-platelet drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Adenomatous PolypsAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesIntestinal PolyposisGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Francis M Giardiello, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

November 1, 2005

First Posted

November 3, 2005

Study Start

November 1, 2005

Primary Completion

June 1, 2008

Last Updated

September 20, 2012

Record last verified: 2012-09