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Chemotherapy Agent
Epidiferphane + Taxane Chemotherapy for Breast Cancer
Phase 1 & 2
Recruiting
Led By Coy Heldermon
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A functioning digestive tract with no obstruction
An ECOG Performance Status less than or equal to 3 based on treating physician assessment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Study Summary
This trialwill test if a nutritional supplement can reduce side effects of chemotherapy for breast cancer patients, potentially improving treatment outcomes.
Who is the study for?
Adults with breast cancer starting a new taxane chemotherapy regimen at UF Health may join this trial. They must have good performance status, no more than one active cancer, and a functioning digestive tract without obstruction. Participants should not be pregnant or breastfeeding, avoid green tea and curcumin supplements, and use effective contraception.Check my eligibility
What is being tested?
The study is testing whether Epidiferphane can reduce side effects like anemia and neuropathy in patients receiving taxane chemotherapy for breast cancer. It will also determine the safety of Epidiferphane and its maximum tolerated dose alongside standard treatment.See study design
What are the potential side effects?
Potential side effects include reactions to ingredients in Epidiferphane (turmeric, broccoli), impact on liver enzymes (ALT/AST levels), kidney function (GFR rate), blood bilirubin levels, as well as possible worsening of existing peripheral sensory or motor neuropathy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My digestive system is working well without blockages.
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I can care for myself but may not be able to do any physical work.
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I am starting treatment for early breast cancer or have metastatic breast cancer for phase I. I have breast cancer of any stage for phase II.
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I am 18 years old or older.
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I am starting a new treatment with specific drugs at UF Health.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cmax of Epidiferphane's components
Cmax of taxanes
Concentration at 24 hours (C24 hours) of Epidiferphane's components
+4 moreSecondary outcome measures
Concentration of the neuropathy marker IL18, as measured by multiplex cytokine bead analysis or ELISA (enzyme-linked immunosorbent assay)
Concentration of the neuropathy marker NF-kB, as measured by multiplex cytokine bead analysis or ELISA (enzyme-linked immunosorbent assay)
Concentration of the neuropathy marker Nrf2, as measured by multiplex cytokine bead analysis or ELISA (enzyme-linked immunosorbent assay)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Epidiferphane + taxane chemotherapyExperimental Treatment2 Interventions
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,631 Total Patients Enrolled
13 Trials studying Breast Cancer
517 Patients Enrolled for Breast Cancer
Coy HeldermonPrincipal InvestigatorUniversity of Florida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My digestive system is working well without blockages.My bilirubin levels are higher than normal, possibly due to Gilbert's Syndrome.I am using effective birth control to prevent pregnancy during the study.Your ALT or AST levels are more than 2.5 times the normal limit.I can care for myself but may not be able to do any physical work.I do not have more than one active cancer.I have not had a red blood cell transfusion in the last 30 days.I am using or willing to use birth control during and for 6 months after the study if I can have children.I don't have any health conditions that my doctor thinks would make the study treatment unsafe for me.My kidney function is reduced.I am starting treatment for early breast cancer or have metastatic breast cancer for phase I. I have breast cancer of any stage for phase II.I have moderate to severe numbness, tingling, or muscle weakness.I will continue my cancer treatment at UF Health for the next 3 months.I am not taking medications like tacrolimus or verapamil.I am 18 years old or older.You are allergic to turmeric, broccoli, or green tea.I do not have a serious or life-threatening infection.I am starting a new treatment with specific drugs at UF Health.I experience tingling or numbness.
Research Study Groups:
This trial has the following groups:- Group 1: Epidiferphane + taxane chemotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the research protocol accept individuals of twenty-one years and older?
"Eligible candidates for this trial must be between the ages of 18 and 99."
Answered by AI
Would I qualify to join this investigation?
"To enroll in this breast cancer clinical trial, candidates should be between 18 and 99 years old. The research team is searching for 74 participants to complete the study."
Answered by AI
Are there still positions available for participants in this experiment?
"Clinicaltrials.gov does not list this trial as actively recruiting, though it was initially posted on December 1st 2022 and last edited six days later. However, there are still 2604 other trials that require patients to take part in them."
Answered by AI
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