Status:
COMPLETED
Changes in Biomarkers of Cancer in Women With Breast Cancer and Without Evidence of Disease Who Were Given PhytoMed™
Lead Sponsor:
Phytogen Medical Foods S.L.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 compl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01819948
Start Date
June 1 2012
Last Update
February 25 2016
Active Locations (5)
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1
Hospital Quirón
Madrid, Madrid, Spain
2
Hospital Universitario La Paz
Madrid, Madrid, Spain
3
Hospital Universitario Puerta de Hierro
Madrid, Madrid, Spain
4
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain