Dietary Bioflavonoid Supplementation for the Prevention of Neoplasia Recurrence

Technische Universität Dresden

Status and phase

Suspended

Phase 2

Conditions

Colorectal Cancer

Treatments

Dietary Supplement: Flavonoids

Study type

Interventional

Funder types

Other

Identifiers

NCT00609310

Flav-Hoe-CCR

Details and patient eligibility

About

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.

Full 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.

Enrollment

382 estimated patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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