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Adenocarcinoma of Colon RecurrentPhase 1/2CRCNCT01402648

Estrogen Receptor Beta Agonists (Eviendep) and Polyp Recurrence

A Phase 1/2 study testing Eviendep (CM&D Pharma Limited, UK) and Maltodextrins in people with Adenocarcinoma of Colon Recurrent, run by CM&D Pharma Limited at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 lignin has been shown to recover ERβ to the healthy wild type levels, and a reduced polyp number and lower dysplasia was… Read more about this study

Who is it for?
Ages 50 to 70 years
Conditions the study is for
Adenocarcinoma of Colon Recurrent
What is being tested?
Eviendep (CM&D Pharma Limited, UK) and Maltodextrins
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteItaly
Study dates
Oct 2009to Apr 2011
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Chronic inflammatory intestinal disease
  • Intestinal and/or extraintestinal malignant neoplasms
  • Acute or chronic renal disease
  • Anemia
  • Coagulation disorders,
  • BMI > 30
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  • Systemic corticosteroids
  • Anticoagulants or platelet antiaggregants
  • Antibiotics within 30 days from enrollment

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Ospedale Policlinico Consorziale - Gastroenterology Unit

    Bari, Bari, 70124

Other trials in Italy

About this study

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

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.

Read the 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, 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.

Being tested
Eviendep (CM&D Pharma Limited, UK), Maltodextrins
Keywords
Non adenomatous mucosa, Estrogen Receptor beta and apoptosis, Adenoma recurrence, Screening colonoscopy every 3-5 years, patients at intermediate risk for CRC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eviendep (CM&D Pharma Limited, UK)Dietary supplement

    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.

  • MaltodextrinsDietary supplement

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

Study groups in NCT01402648
Study groupRoleWhat they receive
Dietary supplementPlacebo comparator900 mg Maltodextrins
Receives: Dietary Supplement: Maltodextrins
Eviendep (CM&D Pharma Limited, UK)Active comparator175 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).
Receives: Dietary Supplement: Eviendep (CM&D Pharma Limited, UK)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Expression of ERβ, ERα, TUNEL, Caspase-3, Ki-67 in bioptic samples of non adenomatous mucosa in sporadic 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.

    Measured: 60 days following dietary oral supplementation, in advance of the screening colonoscopy as per the planning of the surveillance program

Secondary outcomes (2)

  1. Safety assessed by unchanged hematochemistry

    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

    Measured: 30 and 60 days following dietary oral supplementation

  2. Urinary lignans

    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.

    Measured: baseline (T0, 30 (T30) and 60 (T60) days during the study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2011 (estimated)
  2. Study startOct 2009
  3. Primary completionMar 2011
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01402648
Sponsor's protocol ID
CMD-CRC09(2)
Acronym
CRC
Status last verified
Jul 2011
First submitted
25 Jul 2011
Last updated
26 Jul 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Eviendep (CM&D Pharma Limited, UK) and Maltodextrins in people with Adenocarcinoma of Colon Recurrent, run by CM&D Pharma Limited at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01402648.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2011.

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