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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-arm | Experimental | Two capsules in the morning, one at night, every day for a month, taken with a glass of water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PhytoMed™ | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in the levels of CRP | Reduction in serum levels of CRP from selection period to end-of-treatment | Baseline and 33 +/- 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in IL-6 | Reduction in serum levels of IL-6 from selection period to end-of-treatment | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Frequency and intensity of adverse events and frequency of patients with each adverse event. | Form start of treatment to day 60 |
| Toxicity | Frequency and intensity of treatment related adverse events and frequency of patients with each treatment related adverse event. |
Inclusion Criteria:
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.
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:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Muñoz | Phytogen Medical Foods S.L. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Quirón | Madrid | Madrid | Spain | |||
| Hospital Universitario La Paz |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Baseline and 33 +/- 2 days |
| Safety and tolerability (Gastrointestinal symptoms) | Frequency of gastrointestinal adverse events and frequency of patients with gastrointestinal adverse events. | Baseline and 33 +/- 2 days |
| Pain intensity score measured with the BPI scale | Pain reduction from selection period to end-of-treatment | Baseline and 33 +/- 2 days |
| Effect on lipid profile | Changes in lipid profile from selection period to end-of-treatment | Baseline and 33 +/- 2 days |
| Reduction SAA (serum amyloid A) | Reduction in serum levels of SAA from selection period to end-of-treatment | Baseline and 33 +/- 2 days |
| Reduction IFNgamma | Reduction in serum levels of IFN gamma from selection period to end-of-treatment | Baseline and 33 +/- 2 days |
| Reduction TNF-alpha | Reduction in serum levels of TNF-alpha from selection period to end-of-treatment | 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 | Baseline and 33 +/- 2 days |
| Reduction in IGF (insulin growth factor) | Reduction in serum levels of IGF from selection period to end-of-treatment | Baseline and 33 +/- 2 days |
| Form start of treatment to day 60 |
| Madrid |
| Madrid |
| Spain |
| Hospital Universitario Puerta de Hierro | Madrid | Madrid | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Madrid | Spain |
| MD Anderson Cancer Center | Madrid | Madrid | Spain |
| D017437 |
| Skin and Connective Tissue Diseases |