Trial record 3 of 56 for:    pomegranate

Pomegranate Extract Supplementation in Colorectal Cancer Patients (POMEcolon)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hospital Universitario Reina Sofia
Information provided by (Responsible Party):
Juan Carlos Espín de Gea, National Research Council, Spain
ClinicalTrials.gov Identifier:
NCT01916239
First received: July 30, 2013
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

The most relevant pomegranate phenolics (ellagitannins and ellagic acid) are extensively metabolized by the human gut microbiota to yield a number of metabolites called urolithins (mainly Uro-A). Urolithins have been reported to regulate in vivo the expression of genes involved in inflammation and cancer. Our hypothesis is that urolithins can be detected in the human colon mucosa where these metabolites can exert anti-inflammatory and anti-cancer activities. After colonoscopy and diagnosis, colorectal cancer patients will consume capsules containing three different pomegranate extract formulations until surgery. The aims of this trial are:

  • To evaluate the disposition of pomegranate phenolics and urolithins in tumoral and normal colon tissues.
  • To evaluate gene expression profiling and protein markers in tumoral and normal colon tissues from these patients.
  • To compare different pomegranate extract formulations on the above.

Condition Intervention Phase
Colorectal Cancer
Dietary Supplement: Standard pomegranate extract formulation
Dietary Supplement: Pomegranate extract formulation-1
Dietary Supplement: Pomegranate extract formulation-2
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Phase I-II Study of Pomegranate Extract Formulations in Colorectal Cancer Patients: Metabolic and Gene Expression Profiling in Tumoral and Normal Colon Tissues

Resource links provided by NLM:


Further study details as provided by National Research Council, Spain:

Primary Outcome Measures:
  • Phenolics and derived metabolites in colon tissues, plasma and urine. [ Time Frame: Change from baseline at 15 days ] [ Designated as safety issue: No ]
    Occurrence of phenolics and gut-microbiota derived metabolites in tumoral and colon tissues, urine and plasma.

  • Gene expression profiling in colon tissues [ Time Frame: Change from baseline at 15 days ] [ Designated as safety issue: No ]
    Gene expression profile changes in tumoral and normal colon tissues


Secondary Outcome Measures:
  • IGF-1 (insulin-like growth factor-1) [ Time Frame: Change from baseline at 15 days ] [ Designated as safety issue: No ]
    Change in circulating IGF-1 levels

  • CEA (carcnoembryonic antigen) [ Time Frame: Change from baseline at 15 days ] [ Designated as safety issue: No ]
    Change in circulating CEA levels

  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: Change from baseline at 15 days ] [ Designated as safety issue: Yes ]
    • Change in markers involved in hepatic and renal functions: GGT, AST, ALP, ALT, CPK, urate, creatinin, albumin, bilirubin, LDH.
    • Change in hematological variables: leucocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin, hematocrit, mean corpuscular volume, mean platelet volume, platelets, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration.
    • Intolerance, dyspepsia, allergic reactions, constipation, diarrhea, abdominal pain, nausea.

  • microRNA expression profiling in colon tissues [ Time Frame: Change from baseline at 15 days ] [ Designated as safety issue: No ]
    microRNA (miR) expression profile change in tumoral and normal colon tissues


Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard pomegranate extract formulation
Standard pomegranate extract formulation containing 20% punicalagin
Dietary Supplement: Standard pomegranate extract formulation
Standard pomegranate extract formulation containing 20% punicalagin
Experimental: Pomegranate extract formulation-1
New pomegranate extract formulation-1
Dietary Supplement: Pomegranate extract formulation-1
New pomegranate extract formulation-1
Experimental: Pomegranate extract formulation-2
New pomegranate extract formulation-2
Dietary Supplement: Pomegranate extract formulation-2
New pomegranate extract formulation-2

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Colorectal cancer diagnosis.
  • Surgery required.
  • WHO status: between 0 and 2.
  • Hemoglobin >10 g/dL
  • ALT >2.5-fold above the normal value.
  • Serum Bilirubin >1.5-fold above the normal value.
  • Creatinine <140 micromol/L

Exclusion Criteria:

  • Patients who do not satisfy inclusion criteria and,
  • Active pectic ulcer.
  • Pregnancy or breastfeeding.
  • Alcoholism.
  • Chemotherapy or radiotherapy a month prior to recruitment.
  • Treatment with steroids or other anti-inflammatory drugs a week prior to recruitment.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916239

Locations
Spain
Hospital General Universitario Reina Sofía
Murcia, Spain, 30003
Sponsors and Collaborators
National Research Council, Spain
Hospital Universitario Reina Sofia
Investigators
Principal Investigator: Dr. Juan Carlos Espín, PhD National Research Council (CEBAS-CSIC, Murcia, Spain)
  More Information

No publications provided

Responsible Party: Juan Carlos Espín de Gea, Full Research Professor, National Research Council, Spain
ClinicalTrials.gov Identifier: NCT01916239     History of Changes
Other Study ID Numbers: CEBAS-CSIC-2
Study First Received: July 30, 2013
Last Updated: October 7, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by National Research Council, Spain:
Pomegranate
Urolithins
Colorectal cancer
Colon cancer
Metabolite
Gene expression
microRNA
Nutraceutical
Food supplement
Polyphenol
Gut microbiota

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 14, 2014