Phase I/IIa Study of Pharmacokinetics and Safety of Epidiferphane™ and Taxanes in Breast Cancer Patients
Status:
Withdrawn
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
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.