Pomegranate Extract Supplementation in Colorectal Cancer Patients

Colorectal Cancer Clinical Trial

— POMEcolon  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01916239
• Other study ID #: CEBAS-CSIC-2
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 30, 2013
• Last updated: April 13, 2015
• Start date: June 2012
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: National Research Council, Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Dietary Supplement:
• Standard pomegranate extract formulation
Standard pomegranate extract formulation containing 20% punicalagin
• Pomegranate extract formulation-1
New pomegranate extract formulation-1
• Pomegranate extract formulation-2
New pomegranate extract formulation-2

Locations

Country	Name	City	State
Spain	Hospital General Universitario Reina Sofía	Murcia

Sponsors (2)

Lead Sponsor	Collaborator
National Research Council, Spain	Hospital Universitario Reina Sofia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phenolics and derived metabolites in colon tissues, plasma and urine.	Occurrence of phenolics and gut-microbiota derived metabolites in tumoral and colon tissues, urine and plasma.	Change from baseline at 15 days	No
Primary	Gene expression profiling in colon tissues	Gene expression profile changes in tumoral and normal colon tissues	Change from baseline at 15 days	No
Secondary	IGF-1 (insulin-like growth factor-1)	Change in circulating IGF-1 levels	Change from baseline at 15 days	No
Secondary	CEA (carcnoembryonic antigen)	Change in circulating CEA levels	Change from baseline at 15 days	No
Secondary	Number of patients with adverse events as a measure of safety and tolerability	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.	Change from baseline at 15 days	Yes
Secondary	microRNA expression profiling in colon tissues	microRNA (miR) expression profile change in tumoral and normal colon tissues	Change from baseline at 15 days	No