Changes in Biomarkers of Cancer in Women With Breast Cancer and Without Evidence of Disease Who Were Given PhytoMed™

Study Overview
=================
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

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.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: PhytoMed™


Participation Criteria
=================
Eligibility Criteria
-----------------
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: 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. 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-arm<br>Two capsules in the morning, one at night, every day for a month, taken with a glass of water. | Dietary Supplement: PhytoMed™<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Stage 0-IIIA, No evidence of disease