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

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819948
• Other study ID #: Phytomed
• Status: Completed
• Phase: N/A
• First received: March 13, 2013
• Last updated: February 24, 2016
• Start date: June 2012

Study information

• Verified date: February 2016
• Source: Phytogen Medical Foods S.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Dietary Supplement:
• PhytoMed™

Locations

Country	Name	City	State
Spain	Hospital Quirón	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Puerta de Hierro	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	MD Anderson Cancer Center	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Phytogen Medical Foods S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Frequency and intensity of adverse events and frequency of patients with each adverse event.	Form start of treatment to day 60	Yes
Other	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	Yes
Primary	Reduction in the levels of CRP	Reduction in serum levels of CRP from selection period to end-of-treatment	Baseline and 33 +/- 2 days	No
Secondary	Reduction in IL-6	Reduction in serum levels of IL-6 from selection period to end-of-treatment	Baseline and 33 +/- 2 days	No
Secondary	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	No
Secondary	Safety and tolerability (Gastrointestinal symptoms)	Frequency of gastrointestinal adverse events and frequency of patients with gastrointestinal adverse events.	Baseline and 33 +/- 2 days	Yes
Secondary	Pain intensity score measured with the BPI scale	Pain reduction from selection period to end-of-treatment	Baseline and 33 +/- 2 days	No
Secondary	Effect on lipid profile	Changes in lipid profile from selection period to end-of-treatment	Baseline and 33 +/- 2 days	No
Secondary	Reduction SAA (serum amyloid A)	Reduction in serum levels of SAA from selection period to end-of-treatment	Baseline and 33 +/- 2 days	No
Secondary	Reduction IFNgamma	Reduction in serum levels of IFN gamma from selection period to end-of-treatment	Baseline and 33 +/- 2 days	No
Secondary	Reduction TNF-alpha	Reduction in serum levels of TNF-alpha from selection period to end-of-treatment	Baseline and 33 +/- 2 days	No
Secondary	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	No
Secondary	Reduction in IGF (insulin growth factor)	Reduction in serum levels of IGF from selection period to end-of-treatment	Baseline and 33 +/- 2 days	No