Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT03934905
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 to 89 years
2. No prior diagnosis of coronary artery, carotid artery or peripheral artery disease
3. Not pregnant or breastfeeding (urine pregnancy test will be done if female of childbearing potential)
4. Breast cancer requiring treatment with DOX-containing regimen above
5. Women in child bearing age group (18-50 years) will agree to use birth control for duration of study
6. Study subjects must be willing and able to swallow caplets, up to 8 daily.
Exclusion Criteria:
1. Currently on a research study with an investigational drug, or has been on one in the previous 30 days
2. Pregnant (by urine pregnancy test)
3. Baseline ejection fraction of less than 50%, evidence of left ventricular hypertrophy or baseline EKG reported as abnormal per cardiologist.
4. Inability to provide informed consent.
5. Prior history of chest radiation therapy
6. Diabetes or Hypertension or prior Myocardial infarction
7. Trastuzumab patients
8. Routinely taking vegetable or fruit-containing supplement pills (antioxidant phytochemicals) (daily vitamin pills ok)
9. Inability to follow up for safety monitoring
10. Prisoners
11. Previous or current use of cocaine or any illicit drug
12. Unable or unwilling to provide blood samples
13. Taking medications known to have cardiac effects, such as but not limited to, beta blockers, anti-arrhythmic agents, non dihydropyridine calcium channel blockers, ace inhibitors, NSAIDS, diuretic agents.
14. Unable to follow the protocol
15. Inability to receive anthracycline due to any reason (underlying baseline cardiac dysfunction due to other reasons, with an EF under 50%)
16. Patients already taking SFN OTC
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT03934905
Study Brief:
Protocol Section:
NCT03934905