Neoplasms

All Conditions

Symptoms and General Pathology

Adenocarcinoma

Adenoma

Recurrence

Polyps

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Flavonoid

Herbal and Botanical

Estrogens

Silymarin

Milk Thistle

Cola

Flax

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).

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.

Eviendep (CM&D Pharma Limited, UK)

900 mg maltodextrin+excipient as per the active comparator eviendep, up to 5 g/sachet

Maltodextrins

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 lignin has been shown to recover ERβ to the healthy wild type levels, and a reduced polyp number and lower dysplasia was also observed in the adenomatous mucosa. In this randomised, double blind and placebo controlled study, we assessed if ERβ similarly guides the apoptotic control of cell proliferation in the non adenomatous colon mucosa of patients affected from sporadic adenopolyposis, prone to polyp recurrence. For 60 day in advance of the screening colonoscopy, patients were supplemented with a dietary blend of ERβ agonists and lignin (Eviendep, CM\&D Pharma Limited, London, UK) on top their common diet (left unchanged during the study period), to study if the pro-proliferative behavior of the non adenomatous mucosa was effected. Sixty patients naïve from previous and concomitant hormonal or anti-inflammatory CRC chemoprevention were sequentially 1:1 randomised to active or placebo supplementation. ERα and ERβ (mRNA, Western Blotting, Elisa, immunostaining), TUNEL, caspase-3 and Ki-67 (immunostaining) were assessed in bioptic normal colon mucosa samples. Study power: 80%, type 1 error: .05 (two-tails). Statistics: Non parametric Wilcoxon test for efficacy. MANOVA for proliferative and apoptotic biomarkers relationships to the common diet and to the 60 day supplementation.

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, affected by multiple polyps \< 10 mm or one-two adenomas \< 10 mm and/or with a grade of dysplasia to make them classified at intermediate risk for CRC, and scheduled to screening colonoscopy each 3-5 years. Patients were sequentially 1:1 randomly allocated to placebo or Eviendep at baseline (T0). The dietary supplements were administered twice a day for 60 days in advance of the screening colonoscopy, thus covering approximately eight complete colon epithelial turnover to occur. Five days in advance of T60 colonoscopy, patients refrained from fresh and cooked fruit and vegetable intake. Bowel cleansing was achieved by PEG 4000 oral administration (1120 g/4 L water solution). N=8 biopsy samples/patient were collected from the non adenomatous mucosa in the sigmoidal colon. Small polyps (diameter less or equal 0.5 cm) were topically electrocoagulated, whereas villous and tubulovillous polyps (diameter equal or higher than 0.5 cm) were submitted to the histological assessment.

Estrogen Receptor Beta Agonists (Eviendep) and Polyp Recurrence

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

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.

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

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.

CM&D Pharma Limited

Alfredo Di Leo

Colonic Polyps

Disease Attributes

Patients do not receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect

Patients to receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect

Snare Tip Soft Coagulation

No Snare Tip Soft Coagulation

Michael Bourke, FRACP, MBBS

Recurrence after endoscopic mucosal resection of laterally spreading lesions (LSL) \>= 20mm in size occurs in approximately 20% of cases at surveillance colonoscopy. We aim to evaluate the efficacy of prophylactic adjuvant thermal ablation of the EMR mucosal defect margin in reducing adenoma recurrence following colonic EMR.

Patients were blinded to the treatment allocation. The endoscopists performing the index and surveillance procedures were not blinded to the treatment.

Soft Coagulation for the Prevention of Adenoma Recurrence

Soft Coagulation for the Prevention of Adenoma Recurrence After Endoscopic Mucosal Resection (EMR) of Large Sessile Colonic Polyps: A Multicentre, Randomized Trial.

Presence of residual/recurrent adenoma at the EMR scar at endoscopic follow-up

Presence of residual/recurrent adenoma on biopsy of the endoscopic resection scar

Rate of 'en bloc resection' (removing entire lesion in one snare) with histologically confirmed clear margins

The number of snare resections needed to achieve complete clearance

Bleeding after EMR requiring admission or repeat intervention

Number of injections required for haemostasis

Delayed perforation requiring intervention or readmission

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Estrogen Receptor Beta Agonists (Eviendep) and Polyp Recurrence	NCT01402648	Adenocarcinoma ...	Eviendep (CM&D ... Maltodextrins	50 Years - 70 Years	CM&D Pharma Limited
Soft Coagulation for the Prevention of Adenoma Recurrence	NCT01789749	Colonic Adenoma...	Snare Tip Soft ... No Snare Tip So...	18 Years -	Western Sydney Local Health District
Soft Coagulation for the Prevention of Adenoma Recurrence	NCT01789749	Colonic Adenoma...	Snare Tip Soft ... No Snare Tip So...	18 Years -	Western Sydney Local Health District

Spots Global Cancer Trial Database for adenoma recurrence