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

Higher Council for Scientific Research (CSIC)

Status: Completed

Conditions: Breast Cancer

Treatments: Dietary Supplement: Polyphenol

Study type: Interventional

Funder types: Other

Identifiers

NCT03482401

201770E081

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Polyphenol group

Experimental group

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.

Treatment:

Dietary Supplement: Polyphenol

Control group

No Intervention group

Description:

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