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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PhytoMed™
Sponsored by
Phytogen Medical Foods S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast cancer, Stage 0-IIIA, No evidence of disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Hospital Quirón
  • Hospital Universitario La Paz
  • Hospital Universitario Puerta de Hierro
  • Hospital Universitario Ramón y Cajal
  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single-arm

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 13, 2013
Last Updated
February 24, 2016
Sponsor
Phytogen Medical Foods S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT01819948
Brief Title
Changes in Biomarkers of Cancer in Women With Breast Cancer and Without Evidence of Disease Who Were Given PhytoMed™
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phytogen Medical Foods S.L.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Stage 0-IIIA, No evidence of disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single-arm
Arm Type
Experimental
Arm Description
Two capsules in the morning, one at night, every day for a month, taken with a glass of water.
Intervention Type
Dietary Supplement
Intervention Name(s)
PhytoMed™
Primary Outcome Measure Information:
Title
Reduction in the levels of CRP
Description
Reduction in serum levels of CRP from selection period to end-of-treatment
Time Frame
Baseline and 33 +/- 2 days
Secondary Outcome Measure Information:
Title
Reduction in IL-6
Description
Reduction in serum levels of IL-6 from selection period to end-of-treatment
Time Frame
Baseline and 33 +/- 2 days
Title
Increase in the levels of IL-10
Description
Increase in serum levels of IL-10 from selection period to end-of-treatment
Time Frame
Baseline and 33 +/- 2 days
Title
Safety and tolerability (Gastrointestinal symptoms)
Description
Frequency of gastrointestinal adverse events and frequency of patients with gastrointestinal adverse events.
Time Frame
Baseline and 33 +/- 2 days
Title
Pain intensity score measured with the BPI scale
Description
Pain reduction from selection period to end-of-treatment
Time Frame
Baseline and 33 +/- 2 days
Title
Effect on lipid profile
Description
Changes in lipid profile from selection period to end-of-treatment
Time Frame
Baseline and 33 +/- 2 days
Title
Reduction SAA (serum amyloid A)
Description
Reduction in serum levels of SAA from selection period to end-of-treatment
Time Frame
Baseline and 33 +/- 2 days
Title
Reduction IFNgamma
Description
Reduction in serum levels of IFN gamma from selection period to end-of-treatment
Time Frame
Baseline and 33 +/- 2 days
Title
Reduction TNF-alpha
Description
Reduction in serum levels of TNF-alpha from selection period to end-of-treatment
Time Frame
Baseline and 33 +/- 2 days
Title
Increase in the levels of TGFbeta (transforming growth factor beta)
Description
Increase in serum levels of TGF beta from selection period to end-of-treatment
Time Frame
Baseline and 33 +/- 2 days
Title
Reduction in IGF (insulin growth factor)
Description
Reduction in serum levels of IGF from selection period to end-of-treatment
Time Frame
Baseline and 33 +/- 2 days
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
Frequency and intensity of adverse events and frequency of patients with each adverse event.
Time Frame
Form start of treatment to day 60
Title
Toxicity
Description
Frequency and intensity of treatment related adverse events and frequency of patients with each treatment related adverse event.
Time Frame
Form start of treatment to day 60

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Granulocytes ≥ 1,500/µL; Platelets ≥ 100,000/µL; Haemoglobin ≥ 12.0 g/dL; Total bilirubin equal to or below upper limit of normal (ULN); AST and ALT equal to or below ULN; Alkaline phosphatase equal to or below ULN; 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Muñoz
Organizational Affiliation
Phytogen Medical Foods S.L.
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Quirón
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
MD Anderson Cancer Center
City
Madrid
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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