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Dietary Bioflavonoid Supplementation for the Prevention of Neoplasia Recurrence

Primary Purpose

Colorectal Cancer

Status

Suspended

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Flavonoids

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring clinical trial, flavonoid treatment, neoplasia recurrence, colorectal cancer, polypectomy, adenoma in Colon, Neoplasia Recurrence Rates, postpolypectomy patients

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

community Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Flavonoid treatment

Outcomes

Primary Outcome Measures

Recurrence rate of neoplasia

Secondary Outcome Measures

Recurrence free survival, Overall survival, Serum-Flavonoid levels of patients

Full Information

NCT ID

NCT00609310

First Posted

January 24, 2008

Last Updated

February 2, 2012

Sponsor

Technische Universität Dresden

1. Study Identification

Unique Protocol Identification Number

NCT00609310

Brief Title

Dietary Bioflavonoid Supplementation for the Prevention of Neoplasia Recurrence

Official Title

Dietary Supplementation With Bioflavonoids for the Prevention of the Recurrence of Neoplasia in Patients With Resected Colorectal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Suspended

Study Start Date

May 2015 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Technische Universität Dresden

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

clinical trial, flavonoid treatment, neoplasia recurrence, colorectal cancer, polypectomy, adenoma in Colon, Neoplasia Recurrence Rates, postpolypectomy patients

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

382 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Flavonoid treatment

Intervention Type

Dietary Supplement

Intervention Name(s)

Flavonoids

Intervention Description

Nutritional Supplement: flavonoid mixture with 20 mg apigenin and 20 mg epigallocathechin gallate as tablets per day

Primary Outcome Measure Information:

Title

Recurrence rate of neoplasia

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Recurrence free survival, Overall survival, Serum-Flavonoid levels of patients

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harald Hoensch, Professor

Organizational Affiliation

Community Hospital Darmstadt, Germany

Official's Role

Study Chair

Facility Information:

Facility Name

community Hospital

City

Darmstadt

State/Province

Hesse

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Dietary Bioflavonoid Supplementation for the Prevention of Neoplasia Recurrence

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