RecruitingPhase 1 / Phase 2

Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Epidiferphane, a nutrition supplement, in adults with breast cancer who are starting taxane chemotherapy. It will check whether the supplement reduces nerve damage and anemia (too few red blood cells) and helps tumors respond to treatment. It will also test safety and the highest dose patients can tolerate.

Patients with breast cancer are commonly treated with taxane chemotherapy. Some very common side effects of taxanes, such as anemia and peripheral neuropathy, are often as not well addressed during treatment, resulting in dose reductions, dose delays and early discontinuation (collectively called relative dose intensity) of these chemotherapy agents in 15-80 % of patients on these drugs. This reduction in relative dose intensity (RDI) results in worse clinical outcomes such as progression free and overall survival. Pre-clinical studies in mouse models subjected to standardized chemotherapy regimens containing paclitaxel or oxaliplatin have shown that the nutritional supplement Epidiferphane reduces both neuropathy and anemia. This study will investigate whether the use of Epidiferphane in patients with breast cancer receiving taxane chemotherapy results in an attenuation of the side effects experienced, as well as an improvement in tumor response rate. The safety and maximum tolerated dose of Epidiferphane in this patient population will also be determined in this study.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old. For phase I, be starting chemotherapy before surgery or have breast cancer that has spread to other parts of the body. For phase II, any stage or type of breast cancer is allowed.
  • Be starting paclitaxel weekly, docetaxel every 3 weeks, or nab-paclitaxel weekly or every 3 weeks at UF Health, at a dose allowed by the study.
  • Plan to continue cancer treatment at UF Health for at least 3 months.
  • Have a doctor's rating of 0–3 on the ECOG scale, which measures how well you can do daily activities.
  • Have no more than one active cancer, unless the study doctors agree another cancer will not affect study safety or results.
  • Have a working digestive tract with no blockage.
  • Agree to avoid regular green tea use and curcumin supplements, sign a consent form, and follow study procedures.
  • Use approved birth control during the study if you or your partner could become pregnant.

Who can't join

  • Taking another experimental treatment, verapamil, or medicines that strongly block the CYP3A4 enzyme, such as tacrolimus.
  • Pregnant or breastfeeding, or unable or unwilling to use approved birth control for the required time. This includes 6 months after taxane treatment if you could become pregnant, or 3 months if your partner could.
  • Have a serious active infection, an allergy to turmeric, broccoli, or green tea, or another health problem or blood test result that makes treatment unsafe or study results hard to judge.
  • Have a mental health condition or life situation that prevents following study or follow-up rules; are in prison; or are being held against your will, including for medical or mental health treatment.
  • Have sensory or movement-related nerve damage rated grade 2 or higher, or tingling or similar unusual sensations rated grade 1 or higher.
  • Have liver enzymes ALT or AST above 2.5 times the normal upper limit, or bilirubin above 1.5 times that limit. For people with documented Gilbert's syndrome, the bilirubin limit is 3 times normal.
  • Have a kidney filtering rate, called GFR, below 50 mL/min.
  • Received a red blood cell transfusion less than 30 days before treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

FL