Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PhytoMed™ | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single-arm
- description
- Two capsules in the morning, one at night, every day for a month, taken with a glass of water.
- interventionNames
- Dietary Supplement: PhytoMed™
Primary outcomes (1)
- measure
- Reduction in the levels of CRP
- timeFrame
- Baseline and 33 +/- 2 days
- description
- Reduction in serum levels of CRP from selection period to end-of-treatment
Secondary outcomes (10)
- measure
- Reduction in IL-6
- timeFrame
- Baseline and 33 +/- 2 days
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available