Clinical trial NCT01819948: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Stage 0-IIIA
No evidence of disease
Lead sponsor: Phytogen Medical Foods S.L.
Sponsor class: INDUSTRY
First posted: 2013-03-28
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Reduction in the levels of CRP
timeFrame: Baseline and 33 +/- 2 days
Secondary outcomes:
measure: Reduction in IL-6
timeFrame: Baseline and 33 +/- 2 days
measure: Increase in the levels of IL-10
timeFrame: Baseline and 33 +/- 2 days
measure: Safety and tolerability (Gastrointestinal symptoms)
timeFrame: Baseline and 33 +/- 2 days
measure: Pain intensity score measured with the BPI scale
timeFrame: Baseline and 33 +/- 2 days
measure: Effect on lipid profile
timeFrame: Baseline and 33 +/- 2 days
measure: Reduction SAA (serum amyloid A)
timeFrame: Baseline and 33 +/- 2 days
measure: Reduction IFNgamma
timeFrame: Baseline and 33 +/- 2 days
measure: Reduction TNF-alpha
timeFrame: Baseline and 33 +/- 2 days
measure: Increase in the levels of TGFbeta (transforming growth factor beta)
timeFrame: Baseline and 33 +/- 2 days
measure: Reduction in IGF (insulin growth factor)
timeFrame: Baseline and 33 +/- 2 days
Other outcomes:
measure: Adverse Events
timeFrame: Form start of treatment to day 60
measure: Toxicity
timeFrame: Form start of treatment to day 60
Locations:
city: Madrid
country: Spain
facility: Hospital Quirón
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
Study officials:
affiliation: Phytogen Medical Foods S.L.
name: Guillermo Muñoz
role: STUDY_CHAIR
References: