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Polyphenon E in Treating Patients With High-Risk of Colorectal Cancer

NCT01606124 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-10-27

Study results available
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Summary

This phase II trial studies how well Polyphenon E works in treating patients with high-risk of colorectal cancer. Polyphenon E contains ingredients that may prevent or slow colorectal cancer.

Conditions

  • Advanced Colorectal Adenomas
  • Adenocarcinoma of the Colon
  • Stage I Colon Cancer
  • Stage II Colon Cancer
  • Stage III Colon Cancer

Interventions

DRUG

defined green tea catechin extract

Given PO

OTHER

placebo

Given PO

OTHER

questionnaire administration

Ancillary studies

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Frank Sinicrope · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-05-21
Completion
2015-05-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01606124 on ClinicalTrials.gov