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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.


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Reduction in the levels of CRP

Outcome Description:

Reduction in serum levels of CRP from selection period to end-of-treatment

Outcome Time Frame:

Baseline and 33 +/- 2 days

Safety Issue:

No

Principal Investigator

Guillermo Muñoz

Investigator Role:

Study Chair

Investigator Affiliation:

Phytogen Medical Foods S.L.

Authority:

Spain: Agencia Española de Medicamentos y Productos Sanitarios

Study ID:

Phytomed

NCT ID:

NCT01819948

Start Date:

June 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Stage 0-IIIA
  • No evidence of disease
  • Breast Neoplasms

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