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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Dietary Supplement: Polyphenol

• Registration Number: NCT03482401
• Lead Sponsor: National Research Council, Spain

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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-29
• Primary Completion: 2018-12-01
• Study Completion: 2019-12-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polyphenol group	Polyphenol	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.

Primary Outcome Measures

Name	Time	Method
Quantification of dietary polyphenols and methylxanthines in breast tissues	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 Outcome Measures

Name	Time	Method
Quantification of dietary polyphenols and methylxanthines in plasma and urine	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).

Trial Locations

Locations (1)

Hospital General Universitario Reina Sofía; 🇪🇸 Murcia, Spain