An interventional study of Polyphenol in Breast Cancer, sponsored by National Research Council, Spain. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-10.
Sponsored by National Research Council, Spain · Not applicable, Interventional, and Screening
The aim is to characterise the metabolic profiling of dietary polyphenols in normal and malignant breast tissues from breast cancer patients.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 40 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →National Research Council, Spain is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participating patients did not consume the supplement but provided biological samples to the trial
Patients consume 3 capsules/day (474 mg phenolics/day) from the biopsy-confirmed breast cancer diagnosis to the surgery
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.
Time frame: 1-24 months
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).
Time frame: 8-24 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2017 to primary completion in Dec 2018, 18 months.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 18 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Polyphenol
National Research Council, Spain