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

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

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Dietary Supplement: Polyphenol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised, parallel-controlled dietary intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polyphenol group<br>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<br>* Patients consume 3 capsules/day (474 mg phenolics/day) from the biopsy-confirmed breast cancer diagnosis to the surgery<br>|
| No Intervention: Control group<br>Participating patients did not consume the supplement but provided biological samples to the trial | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1-24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 8-24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyphenol, Methylxanthine, Metabolism, Breast tissue, Disposition, UPLC-QTOF