Protective Effects of the Nutritional Supplement Sulforaphane on Doxorubicin-Associated Cardiac Dysfunction

Launched by TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER · Apr 29, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a nutritional supplement called sulforaphane (SFN) when combined with a chemotherapy drug called doxorubicin (DOX) in breast cancer patients. DOX is effective for treating cancer, but it can cause heart problems in some patients. The researchers want to find out if SFN can help protect the heart while still allowing DOX to work effectively against cancer. They believe that SFN may enhance the cancer-fighting effects of DOX and reduce any heart-related side effects that come with it.

To participate in this trial, you need to be between 18 and 89 years old and have breast cancer that requires treatment with DOX. You should not have any serious heart conditions, and women who can become pregnant will need to use birth control during the study. Participants will take SFN in caplet form alongside their DOX treatment. Throughout the trial, researchers will monitor participants' health to ensure the treatment is safe and to see how it affects heart function. This study is currently recruiting participants, and your involvement could contribute to important advancements in cancer treatment safety.

Gender

ALL

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