Using Epidiferphane to Reduce Side Effects of Taxane Chemotherapy in Breast Cancer Patients
Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients
This study is testing if a new drug called Epidiferphane can help breast cancer patients feel better by reducing the side effects of their chemotherapy treatment.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT05074290 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the pharmacokinetics and safety of Epidiferphane in conjunction with taxane chemotherapy for breast cancer patients. The study aims to determine if Epidiferphane can alleviate common side effects associated with taxanes, such as anemia and peripheral neuropathy, which often lead to reduced chemotherapy effectiveness. Patients will be monitored for safety and maximum tolerated doses while assessing tumor response rates. The trial includes both phase I and phase II participants, focusing on those initiating treatment or with metastatic breast cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of breast cancer who are about to start a new taxane chemotherapy regimen.
Not a fit: Patients with more than one active malignancy or those not starting a new taxane treatment regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life and treatment outcomes for breast cancer patients undergoing taxane chemotherapy.
How similar studies have performed: Other studies have shown promising results with similar nutritional supplements in reducing chemotherapy side effects, but this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must be at least 18 years of age * Subjects on the phase I portion must either be initiating neoadjuvant chemotherapy or have a clinical diagnosis of metastatic breast cancer. Subjects on the phase II portion must have a clinical diagnosis of breast cancer of any stage and histology. * Must be about to start a new treatment regimen containing either paclitaxel given weekly or docetaxel given every 3 weeks or nab-paclitaxel given weekly or every 3 weeks at UF Health, at one of the following doses: * Paclitaxel weekly at 80-90 mg/m2 * Nab-paclitaxel weekly at 75-125 mg/m2 or every three weekly at 260 mg/m2 * Docetaxel every three weeks at 75-100 mg/m2 * An ECOG Performance Status less than or equal to 3 based on treating physician assessment * Must continue cancer therapy at UF Health for at least the next three months * Must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treating physician and approved by the PI\] may be included. * A functioning digestive tract with no obstruction * Subjects must be willing to avoid regular consumption of green tea and curcumin supplements for the duration of trial participation. * Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures. * Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study. * Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study. Exclusion Criteria: * Must not be receiving any other investigational agents * Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and following completion of taxane therapy for an additional 6 months for subjects of child bearing potential and 3 months for subjects with partners of child bearing potential. * Subjects who are pregnant or breastfeeding * Active systemic infection considered to be opportunistic, life threatening or clinically significant at the time of treatment. * Psychiatric illness or social situation that would limit compliance with trial requirements. * Known allergy to turmeric, broccoli, or green tea. * Subjects must not be on treatment with strong CYP3A4 inhibitors such as tacrolimus or on verapamil during the trial. * History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding (e.g. hemoglobin \< 10 mg/dL, CTCAE v 5.0 grade 3 or higher neutropenia or thrombocytopenia) giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician. * Prisoners or subjects who are involuntarily incarcerated. * Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness. * Subjects demonstrating an inability to comply with the study and/or follow-up procedures. * CTCAE v 5.0 grade 2 or higher peripheral sensory or motor neuropathy * CTCAE v 5.0 grade 1 or higher paresthesia * Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \>2.5 × the upper limit of normal (ULN) * Total bilirubin (TBL) \>1.5 × ULN or \>3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) * Glomerular filtration rate (GFR) \<50 mL/min * Red blood cell infusions \< 30 days prior to treatment
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Coy Heldermon — University of Florida
- Study coordinator: Priya Gurjar
- Email: PMO@cancer.ufl.edu
- Phone: 352-273-6772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.