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

NCT03482401 — Not applicable, Completed, 40 participants, National Research Council, Spain

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

Registry	NCT03482401, acronym POLYSEN
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, screening
Enrollment	40 (Actual)
Sponsor	National Research Council, Spain (Other gov); collaborators: Hospital General Universitario Reina Sofía de Murcia
Conditions	Breast Cancer
Interventions	Polyphenol (Dietary supplement)
Dates	start 2017-06-01, primary completion 2018-12-01, completion 2019-12-31, first posted 2018-03-29, last updated 2020-09-10
Locations	1 site in Spain

-Summary

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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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Polyphenol group	Experimental	Dietary Supplement: 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.
Control group	No intervention		Participating patients did not consume the supplement but provided biological samples to the trial

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

+Outcome measures

Primary outcomes

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 outcomes

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).

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Hospital General Universitario Reina Sofía	Murcia	Spain

+Investigators

Juan C. Espín, PhD, Principal investigator, National Research Council, Spain