Estrogen Receptor Beta Agonists (Eviendep) and Polyp Recurrence (CRC)
|ClinicalTrials.gov Identifier: NCT01402648|
Recruitment Status : Completed
First Posted : July 26, 2011
Last Update Posted : July 26, 2011
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402648
|Ospedale Policlinico Consorziale - Gastroenterology Unit|
|Bari, Italy, 70124|