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

January 24, 2008
February 2, 2012
May 2015
December 2016   (final data collection date for primary outcome measure)
Recurrence rate of neoplasia [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Recurrence rate of colorectal adenomas and metachronous colorectal cancer and metastasis [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00609310 on ClinicalTrials.gov Archive Site
Recurrence free survival, Overall survival, Serum-Flavonoid levels of patients [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Safety and compliance of long term flavonoid treatment [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Dietary Bioflavonoid Supplementation for the Prevention of Neoplasia Recurrence
Dietary Supplementation With Bioflavonoids for the Prevention of the Recurrence of Neoplasia in Patients With Resected Colorectal Carcinoma

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Colorectal Cancer
Dietary Supplement: Flavonoids
Nutritional Supplement: flavonoid mixture with 20 mg apigenin and 20 mg epigallocathechin gallate as tablets per day
Experimental: I
Flavonoid treatment
Intervention: Dietary Supplement: Flavonoids
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
382
December 2016
December 2016   (final data collection date for primary outcome measure)

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
Both
50 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00609310
Flav-Hoe-CCR
No
Technische Universität Dresden
Technische Universität Dresden
Not Provided
Study Chair: Harald Hoensch, Professor Community Hospital Darmstadt, Germany
Technische Universität Dresden
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP