Using sulforaphane to protect the heart during breast cancer treatment with doxorubicin
Phase II Trial of Effects of the Nutritional Supplement Sulforaphane on Doxorubicin-Associated Cardiac Dysfunction (CRI18-026)
This study is testing if a nutritional supplement called sulforaphane can help protect the hearts of breast cancer patients receiving doxorubicin chemotherapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Texas Tech University Health Sciences Center Academic / other |
| Drugs / interventions | Trastuzumab, radiation, chemotherapy, doxorubicin |
| Locations | 1 site (Lubbock, Texas) |
| Trial ID | NCT03934905 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 89 with breast cancer who require treatment with a doxorubicin-containing regimen.
Not a fit: Patients with pre-existing heart conditions, such as coronary artery disease or those with a baseline ejection fraction of less than 50%, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel approach to protect heart health in breast cancer patients receiving doxorubicin, potentially improving their quality of life and treatment outcomes.
How similar studies have performed: While sulforaphane has been tested in various clinical trials for different conditions, its specific application for preventing DOX-induced cardiotoxicity in breast cancer patients is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lubbock, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.