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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Polyphenol
Sponsored by
National Research Council, Spain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring Polyphenol, Methylxanthine, Metabolism, Breast tissue, Disposition, UPLC-QTOF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital General Universitario Reina Sofía

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Polyphenol group

Control group

Arm Description

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.

Participating patients did not consume the supplement but provided biological samples to the trial

Outcomes

Primary Outcome Measures

Quantification of dietary polyphenols and methylxanthines in breast tissues
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.

Secondary Outcome Measures

Quantification of dietary polyphenols and methylxanthines in plasma and urine
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).

Full Information

First Posted
March 15, 2018
Last Updated
September 8, 2020
Sponsor
National Research Council, Spain
Collaborators
Hospital General Universitario Reina Sofía de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT03482401
Brief Title
Disposition of Dietary Polyphenols and Methylxanthines in Mammary Tissues From Breast Cancer Patients
Acronym
POLYSEN
Official Title
Metabolic Profiling of Dietary Polyphenols and Methylxanthines in Normal and Malignant Mammary Tissues From Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Council, Spain
Collaborators
Hospital General Universitario Reina Sofía de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Polyphenol, Methylxanthine, Metabolism, Breast tissue, Disposition, UPLC-QTOF

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised, parallel-controlled dietary intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polyphenol group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participating patients did not consume the supplement but provided biological samples to the trial
Intervention Type
Dietary Supplement
Intervention Name(s)
Polyphenol
Intervention Description
Patients consume 3 capsules/day (474 mg phenolics/day) from the biopsy-confirmed breast cancer diagnosis to the surgery
Primary Outcome Measure Information:
Title
Quantification of dietary polyphenols and methylxanthines in breast tissues
Description
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.
Time Frame
1-24 months
Secondary Outcome Measure Information:
Title
Quantification of dietary polyphenols and methylxanthines in plasma and urine
Description
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).
Time Frame
8-24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan C. Espín, PhD
Organizational Affiliation
National Research Council, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Universitario Reina Sofía
City
Murcia
ZIP/Postal Code
30003
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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