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

Breast Cancer Clinical Trial

— POLYSEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03482401
• Other study ID #: 201770E081
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2020
• Source: National Research Council, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital General Universitario Reina Sofía	Murcia

Sponsors (2)

Lead Sponsor	Collaborator
National Research Council, Spain	Hospital General Universitario Reina Sofía de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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