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

RecruitingPhase 1, Phase 2Ages 18 Years - 89 YearsAllTexas Tech University Health Sciences Center
NCT03934905 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Cardiomyopathy is a major complication of doxorubicin (DOX) chemotherapy, and 10-21% of breast cancer patients receiving DOX experience compromised cardiac function. Recent advancements have increased cancer survivorship but it remains clinically challenging to mitigate the cardiotoxic side effects. Although there are several strategies used to reduce the occurrence and severity of DOX-induced cardiotoxicity, they are not particularly effective. Hence, there is an urgent need to develop new strategies that prevent the cardiotoxic effects of DOX but maintain its potency as a cancer therapy. Because the cellular events responsible for the antitumor activity of DOX and DOX-induced cardiotoxicity are distinctly different, it may be possible to develop therapies that selectively mitigate DOX-induced cardiotoxicity. Thus, the investigators propose to test an adjuvant therapy that combines the

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📋 Eligibility rules (as published)
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
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What it tests

  • sulforaphane
  • Placebo Oral Tablet
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Where

1 site
Texas Tech University Health Sciences Center
Lubbock, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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