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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
46
Hospital Quirón
Madrid, Madrid, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Hospital Universitario Puerta de Hierro
Madrid, Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Reduction in the levels of CRP
Reduction in serum levels of CRP from selection period to end-of-treatment
Time frame: Baseline and 33 +/- 2 days
Reduction in IL-6
Reduction in serum levels of IL-6 from selection period to end-of-treatment
Time frame: 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
Time frame: Baseline and 33 +/- 2 days
Safety and tolerability (Gastrointestinal symptoms)
Frequency of gastrointestinal adverse events and frequency of patients with gastrointestinal adverse events.
Time frame: Baseline and 33 +/- 2 days
Pain intensity score measured with the BPI scale
Pain reduction from selection period to end-of-treatment
Time frame: Baseline and 33 +/- 2 days
Effect on lipid profile
Changes in lipid profile from selection period to end-of-treatment
Time frame: Baseline and 33 +/- 2 days
Reduction SAA (serum amyloid A)
Reduction in serum levels of SAA from selection period to end-of-treatment
Time frame: Baseline and 33 +/- 2 days
Reduction IFNgamma
Reduction in serum levels of IFN gamma from selection period to end-of-treatment
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MD Anderson Cancer Center
Madrid, Madrid, Spain
Time frame: Baseline and 33 +/- 2 days
Reduction TNF-alpha
Reduction in serum levels of TNF-alpha from selection period to end-of-treatment
Time frame: 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
Time frame: Baseline and 33 +/- 2 days
Reduction in IGF (insulin growth factor)
Reduction in serum levels of IGF from selection period to end-of-treatment
Time frame: Baseline and 33 +/- 2 days