Using sulforaphane to protect the heart during breast cancer treatment with doxorubicin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of the nutritional supplement sulforaphane (SFN) in breast cancer patients undergoing doxorubicin (DOX) chemotherapy. The study aims to determine if SFN can mitigate the cardiotoxic effects associated with DOX while preserving its anti-cancer properties. Researchers will monitor specific biomarkers for early detection of cardiac dysfunction and assess the overall cardiac health of participants. The trial will involve administering SFN or a placebo to eligible patients and evaluating their cardiac function throughout the treatment period.

Why it matters

Who can join: the full rules

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

Where it's running

• Texas Tech University Health Sciences Center
  Lubbock, Texas, United States Recruiting

Study contacts

• Study coordinator: sharda p singh
• Email: sharda.singh@ttuhsc.edu
• Phone: 8067431540

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.