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

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01819948
• Lead Sponsor: Phytogen Medical Foods S.L.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-25
• Study First Posted: 2013-03-28
• Primary Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-24
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Reduction in IL-6	Baseline and 33 +/- 2 days	Reduction in serum levels of IL-6 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 TNF-alpha	Baseline and 33 +/- 2 days	Reduction in serum levels of TNF-alpha 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
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
Safety and tolerability (Gastrointestinal symptoms)	Baseline and 33 +/- 2 days	Frequency of gastrointestinal adverse events and frequency of patients with gastrointestinal adverse events.
Effect on lipid profile	Baseline and 33 +/- 2 days	Changes in lipid profile 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
Pain intensity score measured with the BPI scale	Baseline and 33 +/- 2 days	Pain reduction from selection period to end-of-treatment

Trial Locations

Locations (5)

Hospital Quirón; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Madrid, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

MD Anderson Cancer Center; 🇪🇸 Madrid, Spain