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Trial record 31 of 80 for:    "curcumin" and "cancer"

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 : August 26, 2019
Sponsor:
Collaborator:
Hospital General Universitario Reina Sofía de Murcia
Information provided by (Responsible Party):
National Research Council, Spain

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

Condition or disease Intervention/treatment Phase
Breast Cancer Dietary Supplement: Polyphenol Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, parallel-controlled dietary intervention
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Metabolic Profiling of Dietary Polyphenols and Methylxanthines in Normal and Malignant Mammary Tissues From Breast Cancer Patients
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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

No Intervention: Control group
Participating patients did not consume the supplement but provided biological samples to the trial



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482401


Locations
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Spain
Hospital General Universitario Reina Sofía
Murcia, Spain, 30003
Sponsors and Collaborators
National Research Council, Spain
Hospital General Universitario Reina Sofía de Murcia
Investigators
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Principal Investigator: Juan C. Espín, PhD National Research Council, Spain

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Responsible Party: National Research Council, Spain
ClinicalTrials.gov Identifier: NCT03482401     History of Changes
Other Study ID Numbers: 201770E081
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Research Council, Spain:
Polyphenol
Methylxanthine
Metabolism
Breast tissue
Disposition
UPLC-QTOF
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases