Breast CancerPOLYSENNCT03482401
Disposition of Dietary Polyphenols and Methylxanthines in Mammary Tissues From Breast Cancer Patients
A study testing Polyphenol in people with Breast Cancer, run by National Research Council, Spain at 1 site in Spain.
Trial summary
The aim is to characterise the metabolic profiling of dietary polyphenols in normal and malignant breast tissues from breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Polyphenol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Profiling of Dietary Polyphenols and Methylxanthines in Normal and Malignant Mammary Tissues From Breast Cancer Patients
The aim is to characterise the metabolic profiling of dietary polyphenols in normal and malignant breast tissues from breast cancer patients.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Polyphenol
- Keywords
- Polyphenol, Methylxanthine, Metabolism, Breast tissue, Disposition, UPLC-QTOF
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolyphenolDietary supplement
Patients consume 3 capsules/day (474 mg phenolics/day) from the biopsy-confirmed breast cancer diagnosis to the surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Polyphenol |
| Control group | No intervention | Participating patients did not consume the supplement but provided biological samples to the trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-24 months
Secondary outcomes (1)
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).
Measured: 8-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Jun 2017
- Primary completion1 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, parallel-controlled dietary intervention
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Collaborators
- Hospital General Universitario Reina Sofía de Murcia
- Responsible party
- Principal investigator, Juan Carlos Espín de Gea, National Research Council, Spain
- Investigators
- Juan C. Espín, PhD, Principal investigator, National Research Council, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482401
- Sponsor's protocol ID
- 201770E081
- Acronym
- POLYSEN
- Status last verified
- Sep 2020
- First submitted
- 15 Mar 2018
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Profiling of Dietary Polyphenols and Methylxanthines in Normal and Malignant Mammary Tissues From Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03482401
- Acronym / sponsor ID
- POLYSEN / 201770E081
- Conditions
- Breast Cancer
- Keywords
- Polyphenol, Methylxanthine, Metabolism, Breast tissue, Disposition, UPLC-QTOF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Collaborators
- Hospital General Universitario Reina Sofía de Murcia
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, parallel-controlled dietary intervention
| Arm | Type | Receives |
|---|---|---|
| Polyphenol group | Experimental | Dietary Supplement: PolyphenolPatients 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. |
| Control group | No intervention | –Participating patients did not consume the supplement but provided biological samples to the trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolyphenolPatients consume 3 capsules/day (474 mg phenolics/day) from the biopsy-confirmed breast cancer diagnosis to the surgery | Dietary supplement | Polyphenol group |
Primary outcome
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.
1 secondary outcome
Quantification of dietary polyphenols and methylxanthines in plasma and urine
Time frame: 8-24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan C. Espín, PhD principal investigator
National Research Council, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyphenol in people with Breast Cancer, run by National Research Council, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of dietary polyphenols and methylxanthines in breast tissues (time frame: 1-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.