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

Phytogen Medical Foods

Status

Completed

Conditions

Breast Cancer

Treatments

Dietary Supplement: PhytoMed™

Study type

Interventional

Funder types

Industry

Identifiers

NCT01819948

Phytomed

Details and patient eligibility

About

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

Enrollment

46 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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