Processed SFN-rich extract will be purchased in form of caplets from Nutramax Laboratories, Inc. 2208 Lakeside Blvd Edgewood, MD 21040. Caplets containing SFN-rich broccoli sprout extracts from Nutramax Labs will be dispensed to participants in sealed bottles with instructions to keep them in a household freezer. Size of the caplet will be about 2 cm in length. Dosing will be based on weight and will be dosed daily for 12 weeks.

Placebo caplets will comprise of microcrystalline cellulose from Nutramax Labs and will be dispensed to participants in sealed bottles with instructions to keep them in a household freezer. Placebo pills will be identical in appearance to the sulforaphane pills and will be dosed in a similar manner (identical number of pills based on weight, daily dosing and for 12 weeks)

Anthracycline Related Cardiotoxicity in Breast Cancer

The participants will be dosed, based on weight, in a double-blind fashion with identical appearing placebo or SFN caplets in a daily dose for 12 weeks of: two caplets for individuals <100 lb., four caplets for individuals 100-200 lb. and eight caplets for individuals >200 lb. Avmacol or placebo will be prescribed by Dr. Awasthi and will be dispensed by local pharmacy or study coordinators at TTUHSC/UMC Lubbock. We will be doing pill counts to make sure that volunteers have used as directed. We will measure the Sulforaphane level in plasma by well-established method.

sulforaphane

Placebo Oral Tablet

Texas Tech University Health Sciences Center

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

Phase II Trial of Effects of the Nutritional Supplement Sulforaphane on Doxorubicin-Associated Cardiac Dysfunction (CRI18-026)

2D Echo will be used to measure cardiac function amongst patients on DOX therapy who are exposed to sulforaphane or placebo.

Troponin will be used to assess for cardiotoxicity amongst patients on DOX therapy who are exposed to sulforaphane or placebo.

We will use PET imaging for comparison of change in tumor size for patients on DOX therapy with or without sulforaphane.

All data generated from this project will be disseminated across the scientific community as rapidly as possible while adhering to the NIH Grants Policy on Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Research Resources, issued in November 2016. The data will be available in password protected files, accessible only to investigators and with read only access to the databases. We will follow the guidelines established by NIH for Data Sharing Policy and Implementation and will ensure that all NIH privacy protection procedures are followed. We will make the dataset available to qualified investigators within 6 months of acceptance of the manuscript describing the main study findings. Investigators who request to use the dataset will be required to obtain IRB approval and to sign a data use agreement form before release of the data.

We plan to include 70 DOX-naïve women with breast cancer undergoing neoadjuvant chemotherapy, with no prior cardiac disease and who will receive DOX without Her-2 receptor antagonists as part of their clinical care. Potential subjects will be recruited in a randomized, controlled; double blinded pilot study comparing SFN to placebo. Study will be conducted at the TTUHSC and UMC. The trial is approved by the institutional IRB and will be registered at clinicaltrials.gov. UMC cancer center pharmacist Ajoke A. Tijani, RPh. will receive placebo and test compound from supplier and will dispense them to test subjects. Randomization will be done with assignment of a subject ID to the study subject. The list of subject IDs will be subsequently assigned to either study drug or placebo using a randomizer software.

Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression.

Patients receive oral placebo once daily for 12 months in the absence of disease progression.

BRCA1 Mutation Carrier

BRCA2 Mutation Carrier

cellulose/breast neoplasms

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

Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer

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