Breast Cancer
Conditions
Keywords
Breast cancer, Stage 0-IIIA, No evidence of disease
Brief 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
Interventions
DIETARY_SUPPLEMENTPhytoMed™
Sponsors
Phytogen Medical Foods S.L.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Granulocytes ≥ 1,500/µL; 2. Platelets ≥ 100,000/µL; 3. Haemoglobin ≥ 12.0 g/dL; 4. Total bilirubin equal to or below upper limit of normal (ULN); 5. AST and ALT equal to or below ULN; 6. Alkaline phosphatase equal to or below ULN; 7. 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.
Exclusion criteria
* 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). * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in the levels of CRP | Baseline and 33 +/- 2 days | Reduction in serum levels of CRP from selection period to end-of-treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in IL-6 | Baseline and 33 +/- 2 days | Reduction in serum levels of IL-6 from selection period to end-of-treatment |
| Increase in the levels of IL-10 | Baseline and 33 +/- 2 days | Increase in serum levels of IL-10 from selection period to end-of-treatment |
| Safety and tolerability (Gastrointestinal symptoms) | Baseline and 33 +/- 2 days | Frequency of gastrointestinal adverse events and frequency of patients with gastrointestinal adverse events. |
| Pain intensity score measured with the BPI scale | Baseline and 33 +/- 2 days | Pain reduction from selection period to end-of-treatment |
| Effect on lipid profile | Baseline and 33 +/- 2 days | Changes in lipid profile from selection period to end-of-treatment |
| Increase in the levels of TGFbeta (transforming growth factor beta) | Baseline and 33 +/- 2 days | Increase in serum levels of TGF beta from selection period to end-of-treatment |
| Reduction in IGF (insulin growth factor) | Baseline and 33 +/- 2 days | Reduction in serum levels of IGF from selection period to end-of-treatment |
| Reduction SAA (serum amyloid A) | Baseline and 33 +/- 2 days | Reduction in serum levels of SAA from selection period to end-of-treatment |
| Reduction IFNgamma | Baseline and 33 +/- 2 days | Reduction in serum levels of IFN gamma from selection period to end-of-treatment |
| Reduction TNF-alpha | Baseline and 33 +/- 2 days | Reduction in serum levels of TNF-alpha from selection period to end-of-treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Form start of treatment to day 60 | Frequency and intensity of adverse events and frequency of patients with each adverse event. |
| Toxicity | Form start of treatment to day 60 | Frequency and intensity of treatment related adverse events and frequency of patients with each treatment related adverse event. |
Countries
Spain
Outcome results
None listed