Estrogen Receptor Beta Agonists (Eviendep) and Polyp Recurrence (CRC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01402648 |
Recruitment Status :
Completed
First Posted : July 26, 2011
Last Update Posted : July 26, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adenocarcinoma of Colon Recurrent | Dietary Supplement: Eviendep (CM&D Pharma Limited, UK) Dietary Supplement: Maltodextrins | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Effects of the Dietary Supplementation With a Blend of ER Beta Agonists on the Expression of ER Beta and Related Biomarkers of Cell Proliferation and Apoptosis, in Sporadic Colon Adenopolyposis |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | March 2011 |
Actual Study Completion Date : | April 2011 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Dietary supplement
900 mg Maltodextrins
|
Dietary Supplement: Maltodextrins
900 mg maltodextrin+excipient as per the active comparator eviendep, up to 5 g/sachet |
Active Comparator: Eviendep (CM&D Pharma Limited, UK)
175 mg milk thistle (fruit dry extract, 70% in silymarin)+ 20 mg flaxseed (dry extract, 40% in secoisolariciresinoldiglucoside) + 750 mg non starch, insoluble and indigestible fiber (6% in lignin).
|
Dietary Supplement: Eviendep (CM&D Pharma Limited, UK)
175 mg milk thistle (fruit dry extract, 70% in silymarin)+ 20 mg flaxseed (dry extract, 40% in secoisolariciresinoldiglucoside)+750 mg non-starch, insoluble and indigestible fiber (6% in lignin). Provided in 5 g sachets, to be dissolved in half glass water, administered twice a day for 60 days on top of the common diet. |
- Expression of ERβ, ERα, TUNEL, Caspase-3, Ki-67 in bioptic samples of non adenomatous mucosa in sporadic adenopolyposis [ Time Frame: 60 days following dietary oral supplementation, in advance of the screening colonoscopy as per the planning of the surveillance program ]ERβ and ERα protein content (Elisa), mRNA and immunohistochemically stained cells (% over the total number of cells/field,ICH); TUNEL (%,ICH); caspase-3 (%,ICH), Ki-67 (%ICH), and comparison (mean, median, %ICH) between study groups. Safety assessed by no induction of ERα expression.
- Safety assessed by unchanged hematochemistry [ Time Frame: 30 and 60 days following dietary oral supplementation ]Hemoglobin ≥ 12.0 g/dL; platelets ≥ 120,000/mm3; INR ≤ 1.5; AST or ALT ≤ 1.5 times the upper limit of normal values (ULN); Alkaline Phosphatase ≤ 1.5 times ULN; Bilirubin ≤ 1.5 times ULN; BUN ≤ 40 mg/dL; normal blood pressure or controlled hypertension
- Urinary lignans [ Time Frame: baseline (T0, 30 (T30) and 60 (T60) days during the study period ]To verify comparability of phytoestrogens contributed from the common diet in the two arms at baseline, and to assess compliance to the active comparator during the study period.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men and women, age: 50-70 years
- Menopausal women since at least 2 years
- Diagnosed since 2003 for adenomas, underwent polypectomy and histological assessment
- Regularly inscribed and actively ongoing the surveillance program for the follow-up of adenoma recurrence and progression to advanced adenomas
- Screening colonoscopy every 3-5 years
- No previous or concomitant administration of ASA and NSAIDs
- No previous or concomitant administration of Hormonal Replacement Therapy (HRT)
- No previous or concomitant administration of other phytoestrogens
Exclusion Criteria:
- Chronic inflammatory intestinal disease
- Intestinal and/or extraintestinal malignant neoplasms
- Acute or chronic renal disease
- Anemia
- Coagulation disorders,
- BMI > 30
- Systemic corticosteroids
- Anticoagulants or platelet antiaggregants
- Antibiotics within 30 days from enrollment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402648
Italy | |
Ospedale Policlinico Consorziale - Gastroenterology Unit | |
Bari, Italy, 70124 |
Responsible Party: | Alfredo Di Leo, Head Gastroenterology Unit, D.E.T.O. - University Hospital, Bari (Italy) |
ClinicalTrials.gov Identifier: | NCT01402648 |
Other Study ID Numbers: |
CMD-CRC09(2) |
First Posted: | July 26, 2011 Key Record Dates |
Last Update Posted: | July 26, 2011 |
Last Verified: | July 2011 |
Non adenomatous mucosa Estrogen Receptor beta and apoptosis Adenoma recurrence Screening colonoscopy every 3-5 years patients at intermediate risk for CRC |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |