RECRUITING

Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients

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Breast CancertaxanesEpidiferphane

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients

Quick Facts

Study Start:2023-03-30
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05074290

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must be at least 18 years of age
  2. * 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.
  3. * 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:
  4. * Paclitaxel weekly at 80-90 mg/m2
  5. * Nab-paclitaxel weekly at 75-125 mg/m2 or every three weekly at 260 mg/m2
  6. * Docetaxel every three weeks at 75-100 mg/m2
  7. * An ECOG Performance Status less than or equal to 3 based on treating physician assessment
  8. * Must continue cancer therapy at UF Health for at least the next three months
  9. * 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.
  10. * A functioning digestive tract with no obstruction
  11. * Subjects must be willing to avoid regular consumption of green tea and curcumin supplements for the duration of trial participation.
  12. * Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures.
  13. * Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study.
  14. * Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study.
  1. * Must not be receiving any other investigational agents
  2. * 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.
  3. * Subjects who are pregnant or breastfeeding
  4. * Active systemic infection considered to be opportunistic, life threatening or clinically significant at the time of treatment.
  5. * Psychiatric illness or social situation that would limit compliance with trial requirements.
  6. * Known allergy to turmeric, broccoli, or green tea.
  7. * Subjects must not be on treatment with strong CYP3A4 inhibitors such as tacrolimus or on verapamil during the trial.
  8. * 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.
  9. * Prisoners or subjects who are involuntarily incarcerated.
  10. * Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
  11. * Subjects demonstrating an inability to comply with the study and/or follow-up procedures.
  12. * CTCAE v 5.0 grade 2 or higher peripheral sensory or motor neuropathy
  13. * CTCAE v 5.0 grade 1 or higher paresthesia
  14. * Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \>2.5 × the upper limit of normal (ULN)
  15. * Total bilirubin (TBL) \>1.5 × ULN or \>3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia)
  16. * Glomerular filtration rate (GFR) \<50 mL/min
  17. * Red blood cell infusions \< 30 days prior to treatment

Contacts and Locations

Study Contact

Priya Gurjar
CONTACT
352-273-6772
PMO@cancer.ufl.edu

Principal Investigator

Coy Heldermon
PRINCIPAL_INVESTIGATOR
University of Florida

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32608
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Coy Heldermon, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-30
Study Completion Date2026-01

Study Record Updates

Study Start Date2023-03-30
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

  • breast cancer
  • taxanes
  • Epidiferphane

Additional Relevant MeSH Terms

  • Breast Cancer