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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
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.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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.
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cardiac function after DOX therapy with or without sulforaphane through diagnostic studies
Secondary outcome measures
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)

Find a Location

Who is running the clinical trial?

Texas Tech University Health Sciences CenterLead Sponsor
104 Previous Clinical Trials
10,704 Total Patients Enrolled

Media Library

sulforaphane Clinical Trial Eligibility Overview. Trial Name: NCT03934905 — Phase 1 & 2
Cardiotoxicity Research Study Groups: Placebo, sulforaphane
Cardiotoxicity Clinical Trial 2023: sulforaphane Highlights & Side Effects. Trial Name: NCT03934905 — Phase 1 & 2
sulforaphane 2023 Treatment Timeline for Medical Study. Trial Name: NCT03934905 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap for participants in this experiment?

"Affirmative. According to clinicaltrials.gov, the posting of this medical trial occurred on June 1st 2022 and was revised most recently in July 18th 2022. 70 patients are currently being sought out at one particular site."

Answered by AI

Are there any other precedent experiments concerning the use of sulforaphane?

"At present, 5 clinical trials are being conducted to research sulforaphane's effectiveness. None of these studies have advanced into Phase 3 yet. Primarily located in Piscataway New jersey, there are 4 locations running the medical trial for this therapeutic agent."

Answered by AI

Does this investigation have open recruitment opportunities?

"According to the data hosted on clinicaltrials.gov, this medical trial is actively seeking patients; it was initially posted on June 1st 2022 and revised most recently July 18th 2022."

Answered by AI

Is the age limit for this trial below sixty or above?

"The age limit for this medical trial is 18 to 89, with separate clinical trials available to those under the legal adoption threshold and elderly patients."

Answered by AI

Could I potentially register for this research endeavor?

"This investigation is looking to recruit 70 individuals aged 18 to 89 with cardiotoxicity. Moreover, any female of childbearing age must agree to use birth control throughout the duration of the research; participants should also be able and willing to consume up 8 caplets per day, not have a prior diagnosis of coronary artery disease or similar ailments, nor are pregnant/breastfeeding (urine pregnancy testing will be conducted for applicable candidates)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Protective Effects of the Nutritional Supplement Sulforaphane on Doxorubicin-Associated Cardiac Dysfunction
2022. "Protective Effects of the Nutritional Supplement Sulforaphane on Doxorubicin-Associated Cardiac Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03934905.
~31 spots leftby Nov 2025
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