Study on the Protective Effects of Sulforaphane Supplement on Heart Health During Doxorubicin Chemotherapy

Sponsor: Texas Tech University Health Sciences Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03934905

Provider View

This clinical trial is exploring whether the nutritional supplement sulforaphane can help protect the heart from damage caused by the chemotherapy drug doxorubicin, used in breast cancer treatment, without affecting its ability to fight cancer.

Patient Parameters

Program Overview

Doxorubicin (DOX) is a chemotherapy drug used to treat breast cancer, but it can cause heart problems in some patients. This study is testing if a supplement called sulforaphane (SFN), found in broccoli, can protect the heart from these side effects while still allowing DOX to effectively treat cancer. Researchers believe that SFN might help by activating certain protective mechanisms in the body. The study will involve breast cancer patients receiving DOX treatment to see if SFN is safe and if it reduces heart-related side effects.

Description

This study aims to find out if the supplement sulforaphane (SFN) can safely protect the heart from damage caused by the chemotherapy drug doxorubicin (DOX) in breast cancer patients. DOX is effective in treating cancer but can harm the heart. SFN, a compound found in broccoli, might help by activating protective pathways in the body.

The study will involve up to 70 breast cancer patients who are receiving DOX chemotherapy. Participants will be randomly assigned to receive either SFN or a placebo (a pill with no active ingredient) during their treatment. The study will monitor heart health using echocardiograms and check for any changes in tumor size. Blood samples will be taken to look for markers of heart damage and to see how SFN affects certain genes related to heart protection.

Participants will take SFN or placebo caplets daily for 12 weeks, with the dose based on their weight. The study will ensure that participants are taking the caplets as directed and will monitor for any side effects. If successful, this study could lead to larger trials to confirm SFN's protective effects on the heart during DOX chemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Aged between 18 and 89 years.
  • No history of heart or artery disease.
  • Not pregnant or breastfeeding.
  • Diagnosed with breast cancer requiring DOX chemotherapy.
  • Women of childbearing age must agree to use birth control during the study.
  • Must be able to swallow caplets, up to 8 per day.

Exclusion Criteria

  • Currently or recently (within 30 days) participating in another drug study.
  • Pregnant women.
  • Heart function below a certain level or abnormal heart tests.
  • Unable to give informed consent.
  • History of chest radiation therapy.
  • Have diabetes, high blood pressure, or past heart attack.
  • Taking trastuzumab.
  • Regularly taking supplements with vegetables or fruits (daily vitamins are okay).
  • Unable to attend follow-up appointments.
  • Prisoners.
  • History of drug use.
  • Unable or unwilling to provide blood samples.
  • Taking medications that affect the heart.
  • Unable to follow the study protocol.
  • Unable to receive anthracycline due to heart issues.
  • Already taking sulforaphane supplements.

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