NCT01819948

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 28, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

3.5 years

First QC Date

March 13, 2013

Last Update Submit

February 24, 2016

Conditions

Breast Cancer

Keywords

Breast cancerStage 0-IIIANo evidence of disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Reduction in IL-6

    Baseline and 33 +/- 2 days

  • Increase in the levels of IL-10

    Baseline and 33 +/- 2 days

  • Safety and tolerability (Gastrointestinal symptoms)

    Baseline and 33 +/- 2 days

  • Pain intensity score measured with the BPI scale

    Baseline and 33 +/- 2 days

  • Effect on lipid profile

    Baseline and 33 +/- 2 days

  • +5 more secondary outcomes

Other Outcomes (2)

  • Adverse Events

    Form start of treatment to day 60

  • Toxicity

    Form start of treatment to day 60

Study Arms (1)

single-arm

EXPERIMENTAL

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

Dietary Supplement: PhytoMed™

Interventions

PhytoMed™DIETARY_SUPPLEMENT
single-arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • +5 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Quirón

Madrid, Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Location

MD Anderson Cancer Center

Madrid, Madrid, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Guillermo Muñoz

    Phytogen Medical Foods S.L.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 28, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2015

Last Updated

February 25, 2016

Record last verified: 2016-02

Locations

ES(5)