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

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ClinicalTrials.gov Identifier: NCT03482401
Recruitment Status : Active, not recruiting
First Posted : March 29, 2018
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
Hospital General Universitario Reina Sofía de Murcia
Information provided by (Responsible Party):
National Research Council, Spain

Tracking Information
First Submitted Date  ICMJE March 15, 2018
First Posted Date  ICMJE March 29, 2018
Last Update Posted Date April 3, 2018
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
Quantification of dietary polyphenols and methylxanthines in breast tissues [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03482401 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
Quantification of dietary polyphenols and methylxanthines in plasma and urine [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Disposition of Dietary Polyphenols and Methylxanthines in Mammary Tissues From Breast Cancer Patients
Official Title  ICMJE Metabolic Profiling of Dietary Polyphenols and Methylxanthines in Normal and Malignant Mammary Tissues From Breast Cancer Patients
Brief Summary The aim is to characterise the metabolic profiling of dietary polyphenols in normal and malignant breast tissues from breast cancer patients.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomised, parallel-controlled dietary intervention
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Breast Cancer
Intervention  ICMJE Dietary Supplement: Polyphenol
Patients consume 3 capsules/day (474 mg phenolics/day) from the biopsy-confirmed breast cancer diagnosis to the surgery
Study Arms  ICMJE
  • Experimental: Polyphenol group
    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.
    Intervention: Dietary Supplement: Polyphenol
  • No Intervention: Control group
    Participating patients did not consume the supplement but provided biological samples to the trial
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 22, 2018)
40
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2019
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03482401
Other Study ID Numbers  ICMJE 201770E081
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National Research Council, Spain
Study Sponsor  ICMJE National Research Council, Spain
Collaborators  ICMJE Hospital General Universitario Reina Sofía de Murcia
Investigators  ICMJE
Principal Investigator: Juan C. Espín, PhD National Research Council, Spain
PRS Account National Research Council, Spain
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP