Dietary Bioflavonoid Supplementation for the Prevention of Neoplasia Recurrence

February 2, 2012 updated by: Technische Universität Dresden

Dietary Supplementation With Bioflavonoids for the Prevention of the Recurrence of Neoplasia in Patients With Resected Colorectal Carcinoma

Prove the hypothesis that dietary supplementation with bioflavonoids will diminish the recurrence rate of colonic neoplasia, we will implement a clinical trial comparing bioflavonoids and placebo in a double blind randomized clinical trial. To use a standardised supplementation of bioflavonoids, a commercially available preparation (Flavo-Natin®) will be used.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

The preparation contains a mixture of 200mg chamomile and tea (green tea) extract which contains naturally occurring bioflavonoids (2%) together with vitamins and folic acid. This flavonoids mixture will be applied for 3 years and the compliance and effects of this treatment will be determined by measuring the serum concentrations of apigenin and EGCG of the patients.

Study Type

Interventional

Enrollment (Anticipated)

382

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hesse
      • Darmstadt, Hesse, Germany
        • Community Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient who had a recent surgical resection of colorectal cancer with pathologically proven stage 2 or stage 3 (without adjuvant chemotherapy or after completion of adjuvant chemotherapy) according to UICC. The time interval for recruitment should be within 3-12 month after surgery.
  • Male or female
  • caucasian
  • 50 to 75 years old
  • Broca-index: between -20 and +25%
  • who are willing and capable to confirm written consent to enrolment after ample information has been provided
  • who are in a stable condition that it can be expected that no changes in relevant medical conditions will occur during the study

Exclusion Criteria:

  • subjects with any major relevant clinical abnormality (as based on extensive medical history, physi-cal examination, vital signs)
  • subjects with active cancer
  • subjects with any major clinically relevant laboratory abnormality.
  • subjects who participated in another trial with any investigational substance within the last 4 weeks
  • subjects who are known or suspected to be (social) drug dependent, incl. those drinking more than moderately and who are not willing to abstain from alcohol abuse during the active study phase
  • subjects who adhere to a extreme diet or lifestyle that might interfere with the investigation
  • subjects who are known or suspected not to comply with the study directives and/or who are known or suspected not to be reliable or trustworthy
  • subjects who are known or suspected not to be capable of understanding and evaluating the in-formation that is given to them as part of the formal information policy (informed consent), in par-ticular regarding the risks and discomfort to which they would agree to be exposed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: I
Flavonoid treatment
Dietary supplement: Flavonoids
Nutritional Supplement: flavonoid mixture with 20 mg apigenin and 20 mg epigallocathechin gallate as tablets per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence rate of neoplasia
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrence free survival, Overall survival, Serum-Flavonoid levels of patients
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Investigators

  • Study Chair: Harald Hoensch, Professor, Community Hospital Darmstadt, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

February 6, 2008

First Posted (ESTIMATE)

February 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2012

Last Update Submitted That Met QC Criteria

February 2, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Flav-Hoe-CCR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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