Supplement epidiferphane aims to ease Chemo's harsh side effects
NCT ID NCT05074290
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a nutritional supplement called Epidiferphane can reduce common side effects of taxane chemotherapy, such as nerve damage and anemia, in breast cancer patients. About 74 participants will receive Epidiferphane alongside their standard chemo to see if it helps them stay on full-dose treatment and improves tumor response. The study also checks the supplement's safety and maximum tolerated dose.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 74 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Florida
RECRUITINGGainesville, Florida, 32608, United States
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Other studies related to the condition(s) this trial covers.
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- Can a Decades-Old Anti-Inflammatory drug quiet the joint pain that drives women off breast cancer therapy?