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

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.

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Dietary supplement: PhytoMed™

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Hospital Quirón
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Universitario Ramon Y Cajal
  • Madrid, Spain
    • Hospital Universitario Puerta de Hierro
  • Madrid, Spain
    • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single-arm; Two capsules in the morning, one at night, every day for a month, taken with a glass of water.	Dietary supplement: PhytoMed™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in the levels of CRP	Reduction in serum levels of CRP from selection period to end-of-treatment	Baseline and 33 +/- 2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in IL-6	Reduction in serum levels of IL-6 from selection period to end-of-treatment	Baseline and 33 +/- 2 days
Increase in the levels of IL-10	Increase in serum levels of IL-10 from selection period to end-of-treatment	Baseline and 33 +/- 2 days
Safety and tolerability (Gastrointestinal symptoms)	Frequency of gastrointestinal adverse events and frequency of patients with gastrointestinal adverse events.	Baseline and 33 +/- 2 days
Pain intensity score measured with the BPI scale	Pain reduction from selection period to end-of-treatment	Baseline and 33 +/- 2 days
Effect on lipid profile	Changes in lipid profile from selection period to end-of-treatment	Baseline and 33 +/- 2 days
Reduction SAA (serum amyloid A)	Reduction in serum levels of SAA from selection period to end-of-treatment	Baseline and 33 +/- 2 days
Reduction IFNgamma	Reduction in serum levels of IFN gamma from selection period to end-of-treatment	Baseline and 33 +/- 2 days
Reduction TNF-alpha	Reduction in serum levels of TNF-alpha from selection period to end-of-treatment	Baseline and 33 +/- 2 days
Increase in the levels of TGFbeta (transforming growth factor beta)	Increase in serum levels of TGF beta from selection period to end-of-treatment	Baseline and 33 +/- 2 days
Reduction in IGF (insulin growth factor)	Reduction in serum levels of IGF from selection period to end-of-treatment	Baseline and 33 +/- 2 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Frequency and intensity of adverse events and frequency of patients with each adverse event.	Form start of treatment to day 60
Toxicity	Frequency and intensity of treatment related adverse events and frequency of patients with each treatment related adverse event.	Form start of treatment to day 60

Collaborators and Investigators

• Sponsor: Phytogen Medical Foods S.L.
• Investigators: Study Chair: Guillermo Muñoz, Phytogen Medical Foods S.L.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 13, 2013
• First Submitted That Met QC Criteria: March 25, 2013
• First Posted (Estimate): March 28, 2013

Study Record Updates

• Last Update Posted (Estimate): February 25, 2016
• Last Update Submitted That Met QC Criteria: February 24, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Breast cancer; Stage 0-IIIA; No evidence of disease
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Phytomed