Breast CancerNCT01819948
Changes in Biomarkers of Cancer in Women With Breast Cancer and Without Evidence of Disease Who Were Given PhytoMed™
A study testing PhytoMed™ in people with Breast Cancer, run by Phytogen Medical Foods S.L. at 5 sites in Spain.
Trial summary
The purpose of this study is to determine whether the administration of the PhytoMed™ complement reduces CRP in women with histologically confirmed AJCC Stage 0-IIIA breast cancer which has been completely surgically resected and without evidence of disease as determined by their physician Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- PhytoMed™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 5 sitesSpain
- Study dates
- Jun 2012to Dec 2015
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with histologically confirmed AJCC Stage 0-IIIA breast cancer which has been completely surgically resected.
- No evidence of disease as determined by their physician.
- ER+ and/or PR+ tumour.
- Receiving an aromatase inhibitor (letrozole, anastrazole, exemestane) or tamoxifen at a stable dose for at least 3 months at trial entry.
- Post-menopausal women, defined as: (1) above 50 years of age who have not menstruated during the preceding 12 months or who have follicle-stimulating hormone levels (FSH) > 40 IU/L, (2) those under 50 years of age who have FSH hormone levels >40 IU/L, or (3) those who have undergone a bilateral oophorectomy.
- CRP ≥3.9 mg/L measured as the mean of two consecutive weekly tests.
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- Aged 18 years or older
- ECOG performance status 0-1
- Between 2 and 5 years from their initial surgery for breast cancer.
- Life expectancy of at least 6 months
- At least 6 months since last chemotherapy
- Laboratory tests performed within 14 days of trial starting:
- Granulocytes ≥ 1,500/µL;
- Platelets ≥ 100,000/µL;
- Haemoglobin ≥ 12.0 g/dL;
- Total bilirubin equal to or below upper limit of normal (ULN);
- AST and ALT equal to or below ULN;
- Alkaline phosphatase equal to or below ULN;
- Serum creatinine equal to or below ULN;
- Able to provide informed consent to receive the trial treatment, to provide biological specimens, self-administer oral medica-tion unsupervised for a prolonged period of time, and to complete a medication diary.
Who cannot join
- Pregnancy or breastfeeding
- Who have had a malignancy (other than breast cancer) which required radiotherapy or systemic treatment within the past 5 years.
- Known cardiac disease (arrhythmias, myocardial infarction, bundle branch block, ischemic heart disease, uncontrolled hypertension)
- Known autoimmune disease or inflammatory disorder
- Any condition requiring the use of systemic corticosteroids or any other immunosuppressive agents (e.g. cyclosporin, tacrolimus, azathioprine).
- Women with known immunodeficiency (such as HIV).
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- Patients with infection by septicaemia, infection, acute hepatitis, or other uncontrolled severe medical condition
- Routine use of aspirin >81 mg/d or NSAIDs (> 400 mg po 4 times/day of ibuprofen or naproxen > 500 mg/d) or any use of celecoxib or similar COX-2 inhibitors;
- Subjects are asked not to take dietary supplements, olives or olive oil for 1 month prior to trial enrolment and during the trial.
- Who are taking bisphosphonates
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Quirón
Madrid, Madrid
Hospital Universitario La Paz
Madrid, Madrid
Hospital Universitario Puerta de Hierro
Madrid, Madrid
Hospital Universitario Ramón y Cajal
Madrid, Madrid
MD Anderson Cancer Center
Madrid, Madrid
About this study
Official title: Pilot Clinical Trial to Assess Changes in Biomarkers of Cancer Related to Inflammation in Women With Stage 0-IIIA Breast Cancer and Without Evidence of Disease Who Were Given the PhytoMed™ Complement.
The purpose of this study is to determine whether the administration of the PhytoMed™ complement reduces CRP in women with histologically confirmed AJCC Stage 0-IIIA breast cancer which has been completely surgically resected and without evidence of disease as determined by their physician
- Conditions
- Breast Cancer
- Being tested
- PhytoMed™
- Keywords
- Breast cancer, Stage 0-IIIA, No evidence of disease
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhytoMed™Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| single-arm | Experimental | Two capsules in the morning, one at night, every day for a month, taken with a glass of water. Receives: Dietary Supplement: PhytoMed™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the levels of CRP
Reduction in serum levels of CRP from selection period to end-of-treatment
Measured: Baseline and 33 +/- 2 days
Secondary outcomes (10)
Reduction in IL-6
Reduction in serum levels of IL-6 from selection period to end-of-treatment
Measured: Baseline and 33 +/- 2 days
Increase in the levels of IL-10
Increase in serum levels of IL-10 from selection period to end-of-treatment
Measured: Baseline and 33 +/- 2 days
Safety and tolerability (Gastrointestinal symptoms)
Frequency of gastrointestinal adverse events and frequency of patients with gastrointestinal adverse events.
Measured: Baseline and 33 +/- 2 days
Pain intensity score measured with the BPI scale
Pain reduction from selection period to end-of-treatment
Measured: Baseline and 33 +/- 2 days
Effect on lipid profile
Changes in lipid profile from selection period to end-of-treatment
Measured: Baseline and 33 +/- 2 days
Reduction SAA (serum amyloid A)
Reduction in serum levels of SAA from selection period to end-of-treatment
Measured: Baseline and 33 +/- 2 days
Reduction IFNgamma
Reduction in serum levels of IFN gamma from selection period to end-of-treatment
Measured: Baseline and 33 +/- 2 days
Reduction TNF-alpha
Reduction in serum levels of TNF-alpha from selection period to end-of-treatment
Measured: Baseline and 33 +/- 2 days
Increase in the levels of TGFbeta (transforming growth factor beta)
Increase in serum levels of TGF beta from selection period to end-of-treatment
Measured: Baseline and 33 +/- 2 days
Reduction in IGF (insulin growth factor)
Reduction in serum levels of IGF from selection period to end-of-treatment
Measured: Baseline and 33 +/- 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2015
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phytogen Medical Foods S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guillermo Muñoz, Study chair, Phytogen Medical Foods S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819948
- Sponsor's protocol ID
- Phytomed
- Status last verified
- Feb 2016
- First submitted
- 13 Mar 2013
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial to Assess Changes in Biomarkers of Cancer Related to Inflammation in Women With Stage 0-IIIA Breast Cancer and Without Evidence of Disease Who Were Given the PhytoMed™ Complement.
- ClinicalTrials.gov ID
- NCT01819948
- Acronym / sponsor ID
- Phytomed
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Stage 0-IIIA, No evidence of disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Phytogen Medical Foods S.L.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Dec 2015 (actual)
- First posted
- 28 Mar 2013 (estimated)
- 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 purpose of this study is to determine whether the administration of the PhytoMed™ complement reduces CRP in women with histologically confirmed AJCC Stage 0-IIIA breast cancer which has been completely surgically resected and without evidence of disease as determined by their physician
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm | Experimental | Dietary Supplement: PhytoMed™Two capsules in the morning, one at night, every day for a month, taken with a glass of water. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Women with histologically confirmed AJCC Stage 0-IIIA breast cancer which has been completely surgically resected.
- No evidence of disease as determined by their physician.
- ER+ and/or PR+ tumour.
- Receiving an aromatase inhibitor (letrozole, anastrazole, exemestane) or tamoxifen at a stable dose for at least 3 months at trial entry.
- Post-menopausal women, defined as: (1) above 50 years of age who have not menstruated during the preceding 12 months or who have follicle-stimulating hormone levels (FSH) > 40 IU/L, (2) those under 50 years of age who have FSH hormone levels >40 IU/L, or (3) those who have undergone a bilateral oophorectomy.
Key exclusion criteria (10 listed)
- Pregnancy or breastfeeding
- Who have had a malignancy (other than breast cancer) which required radiotherapy or systemic treatment within the past 5 years.
- Known cardiac disease (arrhythmias, myocardial infarction, bundle branch block, ischemic heart disease, uncontrolled hypertension)
- Known autoimmune disease or inflammatory disorder
- Any condition requiring the use of systemic corticosteroids or any other immunosuppressive agents (e.g. cyclosporin, tacrolimus, azathioprine).
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 |
|---|---|---|
| PhytoMed™ | Dietary supplement | single-arm |
Primary outcome
Reduction in the levels of CRP
Time frame: Baseline and 33 +/- 2 days
Reduction in serum levels of CRP from selection period to end-of-treatment
10 secondary outcomes
Reduction in IL-6
Time frame: Baseline and 33 +/- 2 days
Increase in the levels of IL-10
Time frame: Baseline and 33 +/- 2 days
Safety and tolerability (Gastrointestinal symptoms)
Time frame: Baseline and 33 +/- 2 days
Pain intensity score measured with the BPI scale
Time frame: Baseline and 33 +/- 2 days
Effect on lipid profile
Time frame: Baseline and 33 +/- 2 days
Reduction SAA (serum amyloid A)
Time frame: Baseline and 33 +/- 2 days
Reduction IFNgamma
Time frame: Baseline and 33 +/- 2 days
Reduction TNF-alpha
Time frame: Baseline and 33 +/- 2 days
Increase in the levels of TGFbeta (transforming growth factor beta)
Time frame: Baseline and 33 +/- 2 days
Reduction in IGF (insulin growth factor)
Time frame: Baseline and 33 +/- 2 days
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 25 Feb 2016.
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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.
Guillermo Muñoz study chair
Phytogen Medical Foods S.L.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PhytoMed™ in people with Breast Cancer, run by Phytogen Medical Foods S.L. at 5 sites 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 20 inclusion and 10 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 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Reduction in the levels of CRP (time frame: Baseline and 33 +/- 2 days). 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 25 Feb 2016.