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Sulforaphane for Chemotherapy-Related Cardiotoxicity

Phase 1 & 2

Recruiting

Research Sponsored by Texas Tech University Health Sciences Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Study subjects must be willing and able to swallow caplets, up to 8 daily.

No prior diagnosis of coronary artery, carotid artery or peripheral artery disease

Must not have

Inability to receive anthracycline due to any reason (underlying baseline cardiac dysfunction due to other reasons, with an EF under 50%)

Baseline ejection fraction of less than 50%, evidence of left ventricular hypertrophy or baseline EKG reported as abnormal per cardiologist.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, prior to each cycle of dox, at completion of 4th cycle of dox therapy and 1 year from baseline assessment.

Summary

This trial is testing whether adding the phytochemical sulforaphane to standard doxorubicin chemotherapy can reduce cardiotoxicity without reducing the cancer-fighting effects.

Who is the study for?

Adults aged 18-89 with breast cancer needing DOX treatment, without prior heart disease, diabetes, hypertension or myocardial infarction. Must not be pregnant/breastfeeding and willing to use birth control if of childbearing age. Participants should be able to swallow caplets and provide blood samples.

What is being tested?

The trial is testing whether the nutritional supplement sulforaphane can protect against heart damage caused by the chemotherapy drug doxorubicin in breast cancer patients, without affecting its anti-cancer effectiveness.

What are the potential side effects?

Potential side effects are not detailed here but may include typical reactions to nutritional supplements such as gastrointestinal discomfort. Close monitoring will assess any impact on cardiac function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow up to 8 pills daily.

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I have never been diagnosed with heart or artery disease.

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I am between 18 and 89 years old.

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My breast cancer treatment includes DOX.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot receive anthracycline treatment due to heart issues.

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My heart's pumping ability is below normal, or I have an enlarged heart or abnormal heart rhythm.

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I am currently taking SFN as an over-the-counter supplement.

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I have had radiation therapy to my chest before.

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I am taking medications that can affect my heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, prior to each cycle of dox, at completion of 4th cycle of dox therapy and 1 year from baseline assessment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, prior to each cycle of dox, at completion of 4th cycle of dox therapy and 1 year from baseline assessment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, prior to each cycle of dox, at completion of 4th cycle of dox therapy and 1 year from baseline assessment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in cardiac function after DOX therapy with or without sulforaphane through diagnostic studies

Secondary study objectives

Elevation of troponin levels as a surrogate evidence of DOX related cardiotoxicity will be checked at baseline, prior to each DOX therapy and then at 1 year from baseline assessment (Each cycle is 14 days).

Tumor size in patients on DOX therapy with or without sulforaphane treatment will be assessed at baseline, at completion of DOX chemotherapy (4 cycles planned with each cycle being 14 days) and at 1 year from baseline assessment.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: sulforaphaneActive Control1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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)

0 / 9Eligibility criteria met