Status:
COMPLETED
Estrogen Receptor Beta Agonists (Eviendep) and Polyp Recurrence
Lead Sponsor:
CM&D Pharma Limited
Conditions:
Adenocarcinoma of Colon Recurrent
Eligibility:
All Genders
50-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The decreased Estrogen Receptor beta (ERβ) expression in the non adenomatous mucosa of ApcMin/+ mice favours intestinal neoproliferation. The dietary supplementation with a blend of ERβ agonists and l...
Detailed Description
Enrolled patients were actively ongoing the surveillance program for the follow up of polyp recurrence and progression to CRC. Eligible patients should have undergone a polypectomy since 2003, affecte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01402648
Start Date
October 1 2009
End Date
April 1 2011
Last Update
July 26 2011
Active Locations (1)
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1
Ospedale Policlinico Consorziale - Gastroenterology Unit
Bari, Bari, Italy, 70124