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


Phase 2
50 Years
75 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Recurrence rate of neoplasia

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Harald Hoensch, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

Community Hospital Darmstadt, Germany

Authority:

Germany: Federal Ministry of Food, Agriculture and Consumer Protection

Study ID:

Flav-Hoe-CCR

NCT ID:

NCT00609310

Start Date:

May 2015

Completion Date:

December 2016

Related Keywords:

  • Colorectal Cancer
  • clinical trial
  • flavonoid treatment
  • neoplasia recurrence
  • colorectal cancer
  • polypectomy
  • adenoma in Colon
  • Neoplasia Recurrence Rates
  • postpolypectomy patients
  • Neoplasms
  • Colorectal Neoplasms
  • Recurrence

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