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.
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) |
I: Experimental
Flavonoid treatment
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Dietary Supplement: Flavonoids
Nutritional Supplement: flavonoid mixture with 20 mg apigenin and 20 mg epigallocathechin gallate as tablets per day
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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).