Dietary Bioflavonoid Supplementation for the Prevention of Neoplasia Recurrence

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. Identifier: NCT00609310
Recruitment Status : Suspended
First Posted : February 7, 2008
Last Update Posted : February 3, 2012
Information provided by (Responsible Party):
Technische Universität Dresden

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Dietary Supplement: Flavonoids Phase 2

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  (Clinical Trial)
Estimated Enrollment : 382 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Dietary Supplementation With Bioflavonoids for the Prevention of the Recurrence of Neoplasia in Patients With Resected Colorectal Carcinoma
Study Start Date : May 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Recurrence rate of neoplasia [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Recurrence free survival, Overall survival, Serum-Flavonoid levels of patients [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00609310

community Hospital
Darmstadt, Hesse, Germany
Sponsors and Collaborators
Technische Universität Dresden
Study Chair: Harald Hoensch, Professor Community Hospital Darmstadt, Germany

Responsible Party: Technische Universität Dresden Identifier: NCT00609310     History of Changes
Other Study ID Numbers: Flav-Hoe-CCR
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: February 2012

Keywords provided by Technische Universität Dresden:
clinical trial
flavonoid treatment
neoplasia recurrence
colorectal cancer
adenoma in Colon
Neoplasia Recurrence Rates
postpolypectomy patients

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Disease Attributes
Pathologic Processes