Flavonoids to Prevent Recurrence in Patients With Resected Colorectal Cancer or Colorectal Adenomas - Full Text View

Sponsored by:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00609310

Purpose

The purpose of this study is to evaluate whether the neoplasia recurrence in high risk patients with resected colorectal cancer (UICC grade I, II and III) can be reduced by flavonoids supplied as an nutritional supplement.

Furthermore we try to evaluate whether the recurrence rate of adenomas in postpolypectomy patients can be diminished by oral flavonoids.

To reach this goal one stratum of these patients is treated with an oral flavonoid mixture on a long term basis for 3 years and compared with the corresponding stratum of patients without this intervention.

Condition	Intervention	Phase
Resected Colorectal Cancer	Dietary Supplement: Flavonoids	Phase II Phase III

MedlinePlus related topics: Cancer Colorectal Cancer Dietary Supplements

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Active Control, Single Group Assignment
Official Title:	Open Clinical Trial to Compare Flavonoid Treatment With Passive Control Patients Not Exposed to Evaluate Neoplasia Recurrence Rates in Resected Colorectal Cancer and Postpolypectomy Patients

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

Recurrence rate of colorectal adenomas and metachronous colorectal cancer and metastasis [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety and compliance of long term flavonoid treatment [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	600
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Flavonoid treatment	Dietary Supplement: Flavonoids Nutritional Supplement: flavonoid mixture with 20 mg apigenin and 20 mg epigallocathechin gallate as tablets per day

Detailed Description:

In the treated cohort the patients take 2 tablets of the supplement daily for 3 years by the oral route. To determine compliance before and on flavonoid treatment steady state flavonoid plasma levels will be measured (total catechins, apigenin, quercetin and kaempferol concentrations).

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years to 80 years
Both genders
Patients in stable medical condition after curative resection of colorectal cancer or after polypectomy of adenoma
Caucasian
Broca Index between -20 and plus 25%
Who are willing and capable to confirm written consent for recruitment after ample information has been provided
Are in stable condition that it can be expected that note changes in relevant health conditions will occur during the study.

Exclusion Criteria:

Subjects with any major relevant clinical formality (as based on extensive medical history, physical examination),
Subjects with any major clinically relevant laboratory abnormality,
Subjects who are known or suspected to be drug dependent, including those who drink more than moderately.
Subjects who adhere to a diet or lifestyle that might interfere with the investigation,
Subjects who are known or suspected not to comply with the study directions and or are known or suspected to be not reliable,
Subjects who are known or suspected not to be capable of understanding and the information that is given to them as product of the formal study initiation.

Contacts and Locations

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

Contacts

Contact: Joachim Siegert, MD, PhD

+49 351 458 5694

joachim.siegert@mailbox.tu-dresden.de

Locations

Germany, Hesse
community Hospital
Darmstadt, Hesse, Germany

Sponsors and Collaborators

Dresden University of Technology

Investigators

Principal Investigator:

Harald Hoensch, Professor

Community Hospital Darmstadt, Germany

More Information

Responsible Party:	Dresden University of Technology, Institute for Clinical Pharmacology ( Joachim Siegert )
Study ID Numbers:	Flav-Hoe-CCC
Study First Received:	January 24, 2008
Last Updated:	February 6, 2008
ClinicalTrials.gov Identifier:	NCT00609310
Health Authority:	Germany: Federal Ministry of Food, Agriculture and Consumer Protection

Keywords provided by Dresden University of Technology:

clinical trial
flavonoid treatment
neoplasia recurrence
colorectal cancer

polypectomy
adenoma in Colon
Neoplasia Recurrence Rates
postpolypectomy patients

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases

Rectal Diseases
Adenoma
Intestinal Neoplasms
Recurrence
Colorectal Neoplasms

Additional relevant MeSH terms:

Disease Attributes
Neoplasms
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009