Dietary Bioflavonoid Supplementation for the Prevention of Neoplasia Recurrence
This study has suspended participant recruitment.
Sponsor:
Dresden University of Technology
Information provided by (Responsible Party):
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00609310
First received: January 24, 2008
Last updated: February 2, 2012
Last verified: February 2012
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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 Dresden University of Technology:
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 More Information
No publications provided
| Responsible Party: | Dresden University of Technology |
| 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 Dresden University of Technology:
|
clinical trial flavonoid treatment neoplasia recurrence colorectal cancer |
polypectomy adenoma in Colon Neoplasia Recurrence Rates postpolypectomy patients |
Additional relevant MeSH terms:
|
Neoplasms Colorectal Neoplasms Recurrence Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013