Dietary Bioflavonoid Supplementation for the Prevention of Neoplasia Recurrence

NCT00609310 | Suspended Phase 2

• 1 other identifier: Flav-Hoe-CCR
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

clinical trial; flavonoid treatment; neoplasia recurrence; colorectal cancer; polypectomy; adenoma in Colon; Neoplasia Recurrence Rates; postpolypectomy patients

Outcome Measures

Primary Outcomes (1)

• Recurrence rate of neoplasia

  3 years

Secondary Outcomes (1)

• Recurrence free survival, Overall survival, Serum-Flavonoid levels of patients

  3 years

Study Arms (1)

I

EXPERIMENTAL

Flavonoid treatment

Dietary Supplement: Flavonoids

Interventions

Flavonoids DIETARY_SUPPLEMENT

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

I

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

community Hospital

Darmstadt, Hesse, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Flavonoids

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Harald Hoensch, Professor

  Community Hospital Darmstadt, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: February 7, 2008
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 3, 2012

Record last verified: 2012-02

Locations

DE (1)