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

NCT ID: NCT01819948

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30

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

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

single-arm

Two capsules in the morning, one at night, every day for a month, taken with a glass of water.

Group Type: EXPERIMENTAL

PhytoMed™

Intervention Type: DIETARY_SUPPLEMENT

Interventions

PhytoMed™

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Phytogen Medical Foods S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillermo Muñoz

Role: STUDY_CHAIR

Phytogen Medical Foods S.L.

Locations

Hospital Quirón

Madrid, Madrid, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro

Madrid, Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

MD Anderson Cancer Center

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

Phytomed

Identifier Type: -

Identifier Source: org_study_id