Study on the Safety and Effects of Epidiferphane and Taxane Chemotherapy in Breast Cancer Patients
Sponsor: University of Florida
ClinicalTrials ID:NCT05074290
This clinical trial is exploring whether a nutritional supplement called Epidiferphane can help reduce common side effects of taxane chemotherapy, such as anemia and nerve damage, in breast cancer patients. The study will also determine the safest dose of Epidiferphane and see if it improves the response to cancer treatment.
Patient Parameters
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Program Overview
This study aims to find out if Epidiferphane, a nutritional supplement, can lessen the side effects of taxane chemotherapy, which is commonly used to treat breast cancer. These side effects often include anemia and nerve damage, which can lead to reduced doses or delays in treatment, affecting patient outcomes. The study will also assess the safety and best dose of Epidiferphane for patients undergoing this treatment.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- For Phase I: Starting chemotherapy for breast cancer or diagnosed with metastatic breast cancer.
- For Phase II: Diagnosed with breast cancer at any stage.
- Starting a new treatment with specific chemotherapy drugs (paclitaxel, docetaxel, or nab-paclitaxel) at UF Health.
- Must have a performance status score of 3 or less, indicating ability to perform daily activities.
- Must continue cancer treatment at UF Health for at least three months.
- No more than one active cancer at the time of joining the study.
- Must have a working digestive system without blockages.
- Must avoid regular green tea and curcumin supplements during the study.
- Must provide written consent and be able to follow study procedures.
- Women of childbearing age must use effective birth control during the study.
- Men with partners of childbearing age must agree to use effective birth control methods.
Exclusion Criteria
- Cannot be taking other experimental drugs.
- Women who are pregnant or breastfeeding cannot participate.
- Must not have any serious infections at the time of treatment.
- Cannot have psychiatric or social issues that would prevent following the study requirements.
- Must not be allergic to turmeric, broccoli, or green tea.
- Cannot be taking certain medications that interfere with the study drugs.
- Must not have any other health conditions that could complicate treatment or affect study results.
- Cannot be in prison or involuntarily detained.
- Must not have severe nerve damage or liver issues.
- Must not have had a blood transfusion within 30 days before starting treatment.
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