Dietary Bioflavonoid Supplementation for the Prevention of Neoplasia Recurrence

NCT ID: NCT00609310

Last Updated: 2012-02-03

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 382 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-12-31

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.

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

I

Flavonoid treatment

Group Type: EXPERIMENTAL

Flavonoids

Intervention Type: DIETARY_SUPPLEMENT

Nutritional Supplement: flavonoid mixture with 20 mg apigenin and 20 mg epigallocathechin gallate as tablets per day

Interventions

Flavonoids

Nutritional Supplement: flavonoid mixture with 20 mg apigenin and 20 mg epigallocathechin gallate as tablets per day

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harald Hoensch, Professor

Role: STUDY_CHAIR

Community Hospital Darmstadt, Germany

Locations

community Hospital

Darmstadt, Hesse, Germany

Countries

Germany

Other Identifiers

Flav-Hoe-CCR

Identifier Type: -

Identifier Source: org_study_id