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NCT Number: NCT03482401

Disposition of Dietary Polyphenols and Methylxanthines in 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Universitario Reina Sofía

Murcia, 30003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polyphenol

Dietary Supplement

Patients consume 3 capsules/day (474 mg phenolics/day) from the biopsy-confirmed breast cancer diagnosis to the surgery

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Collaborators

  • Hospital General Universitario Reina Sofía de Murcia

Registry information

Official study title

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

Acronym: POLYSEN

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 29, 2018
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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