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New treatment option for Anthracycline Related Cardiotoxicity in Breast Cancer
Official title Protective Effects of the Nutritional Supplement Sulforaphane on Doxorubicin-Associated Cardiac Dysfunction
ClinicalTrials.gov ID: NCT03934905
What this study is testing
What is sulforaphane?
sulforaphane is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for anthracycline related cardiotoxicity in breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- Age 18 to 89 years
- No prior diagnosis of coronary artery, carotid artery or peripheral artery disease
- Not pregnant or breastfeeding (urine pregnancy test will be done if female of childbearing potential)
- Breast cancer requiring treatment with DOX-containing regimen above
- Women in child bearing age group (18-50 years) will agree to use birth control for duration of study
You likely can't join if
- Currently on a research study with an investigational drug, or has been on one in the previous 30 days
- Pregnant (by urine pregnancy test)
- Baseline ejection fraction of less than 50%, evidence of left ventricular hypertrophy or baseline EKG reported as abnormal per cardiologist.
- Inability to provide informed consent.
- Prior history of chest radiation therapy
- Diabetes or Hypertension or prior Myocardial infarction
See the full eligibility criteria
- Age 18 to 89 years
- No prior diagnosis of coronary artery, carotid artery or peripheral artery disease
- Not pregnant or breastfeeding (urine pregnancy test will be done if female of childbearing potential)
- Breast cancer requiring treatment with DOX-containing regimen above
- Women in child bearing age group (18-50 years) will agree to use birth control for duration of study
- Study people must be willing and able to swallow caplets, up to 8 daily.
- Currently on a research study with an investigational drug, or has been on one in the previous 30 days
- Pregnant (by urine pregnancy test)
- Baseline ejection fraction of less than 50%, evidence of left ventricular hypertrophy or baseline EKG reported as abnormal per cardiologist.
- Inability to provide informed consent.
- Prior history of chest radiation therapy
- Diabetes or Hypertension or prior Myocardial infarction
- Trastuzumab patients
- Routinely taking vegetable or fruit-containing supplement pills (antioxidant phytochemicals) (daily vitamin pills ok)
- Inability to follow up for safety monitoring
- Prisoners
- Previous or current use of cocaine or any illicit drug
- Unable or unwilling to provide blood samples
- 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.
- Unable to follow the protocol
- Inability to receive anthracycline due to any reason (underlying baseline cardiac dysfunction due to other reasons, with an EF under 50%)
- Patients already taking SFN OTC
The study team makes the final eligibility decision.
Where it's taking place
- Lubbock, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lubbock, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.