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Dietary Bioflavonoid Supplementation for the Prevention of Neoplasia Recurrence

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00609310
First received: January 24, 2008
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Colorectal Cancer
Dietary Supplement: Flavonoids
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Dietary Supplementation With Bioflavonoids for the Prevention of the Recurrence of Neoplasia in Patients With Resected Colorectal Carcinoma

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Recurrence rate of neoplasia [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrence free survival, Overall survival, Serum-Flavonoid levels of patients [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 382
Study Start Date: May 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Flavonoid treatment
Dietary Supplement: Flavonoids
Nutritional Supplement: flavonoid mixture with 20 mg apigenin and 20 mg epigallocathechin gallate as tablets per day

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609310

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

No publications provided

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT00609310     History of Changes
Other Study ID Numbers: Flav-Hoe-CCR
Study First Received: January 24, 2008
Last Updated: February 2, 2012
Health Authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection

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

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

ClinicalTrials.gov processed this record on November 20, 2014