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.
- 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.
- 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