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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03611985
Study type Interventional
Source University of Florida
Contact Allison Allegra, MPH
Phone (352) 273-5079
Email allisonallegra3@ufl.edu
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date October 2018
Completion date September 2021

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