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

NCT03482401 | Completed

• 1 other identifier: 201770E081
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Polyphenol; Methylxanthine; Metabolism; Breast tissue; Disposition; UPLC-QTOF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quantification of dietary polyphenols and methylxanthines in plasma and urine

  8-24 months

Study Arms (2)

Polyphenol group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Polyphenol DIETARY_SUPPLEMENT

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

Polyphenol group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Council, Spain: lead
• Hospital General Universitario Reina Sofía de Murcia: collaborator

Study Sites (1)

Hospital General Universitario Reina Sofía

Murcia, 30003, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Polyphenols

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Juan C. Espín, PhD

  National Research Council, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Model Details: Randomised, parallel-controlled dietary intervention

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 29, 2018
• Study Start: June 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 31, 2019
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)