Disposition of Dietary Polyphenols and Methylxanthines in Mammary Tissues From Breast Cancer Patients (POLYSEN)

September 8, 2020 updated by: Juan Carlos Espín de Gea, National Research Council, Spain

Metabolic Profiling of Dietary Polyphenols and Methylxanthines in Normal and Malignant Mammary Tissues From Breast Cancer Patients

The aim is to characterise the metabolic profiling of dietary polyphenols in normal and malignant breast tissues from breast cancer patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this exploratory trial is to determine the disposition and characterise the metabolic profiling of dietary polyphenols in normal and malignant glandular breast tissues from newly diagnosed breast cancer patients.

The patients consumed a polyphenol-rich dietary supplement containing 37 different phenolics and 2 methylxanthines (theobromine and caffeine) from the diagnosis to the surgery. The metabolic profiling was characterized in normal and malignant breast tissues as well as plasma and urine using UPLC-ESI-QTOF-MS/MS.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30003
        • Hospital General Universitario Reina Sofía

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eligible patients are those over 18 years with a newly biopsy-confirmed breast cancer, programmed surgery at least 3 days after the recruitment and no neoadjuvant treatment.

Exclusion Criteria:

  • Suspected intolerance to any component of fruits or vegetables.
  • Neoadjuvant chemo- or radiotherapy.
  • Urgent surgery (less than 3 days after the recruitment).
  • Patient under 18 years.
  • Patient with breast adenoma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Polyphenol group
Patients consumed a polyphenol-rich dietary supplement (commercial lemon, orange, pomegranate, olive, grape, cocoa, curcuma and broccoli extracts), mainly rich in simple phenolics such as hydroxytyrosol and the polyphenols procyanidins, hesperidin, eriocitrin, curcumin, resveratrol, punicalagin and ellagic acid. Cocoa extract also contains the methylxanthines theobromine and caffeine.
Dietary supplement: Polyphenol
Patients consume 3 capsules/day (474 mg phenolics/day) from the biopsy-confirmed breast cancer diagnosis to the surgery
No Intervention: Control group
Participating patients did not consume the supplement but provided biological samples to the trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of dietary polyphenols and methylxanthines in breast tissues
Time Frame: 1-24 months

Quantification of dietary polyphenols and methylxanthines in normal and malignant mammary tissues from breast cancer patients using ultra-high resolution liquid chromatography coupled to quadrupole-time-of-flight mass spectrometry (UPLC-ESI-QTOF-MS/MS).

  • Quantification (pmol/g) of each phenolic-derived metabolite in breast tissues.
  • Quantification (pmol/g) of each methylxanthine-derived metabolite in breast tissues.
1-24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of dietary polyphenols and methylxanthines in plasma and urine
Time Frame: 8-24 months

Quantification of dietary polyphenols and methylxanthines in urine and plasma from breast cancer patients using ultra-high resolution liquid chromatography coupled to quadrupole-time-of-flight mass spectrometry (UPLC-ESI-QTOF-MS/MS).

  • Quantification of each phenolic-derived metabolite in urine and plasma (nmol/L).
  • Quantification of each methylxanthine-derived metabolite in urine and plasma (nmol/L).
8-24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Council, Spain

Collaborators

Hospital General Universitario Reina Sofía de Murcia

Investigators

  • Principal Investigator: Juan C. Espín, PhD, National Research Council, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

March 22, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

September 10, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201770E081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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