Last updated on August 2019

Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)


Brief description of study

This is a prospective natural history study of CIPN in approximately 200 participants receiving taxanes (paclitaxel, docetaxel) for breast cancer or vincristine for lymphoma. Participants will be enrolled over approximately 1-year. Demographic data, medical history, electronic PROs, ClinROs and NF-L will be assessed at Baseline. The Observation Period will initiate with the first dose of chemotherapy and conclude with the last dose of chemotherapy. During the Observation Period, participants will be evaluated for the development of CIPN using PROs and ClinROs. NF-L will be measured at various timepoints corresponding with treatment regimen schedules throughout the Observation Period. The Post Chemotherapy Follow-up Period will begin with the first visit after the last dose of chemotherapy and conclude 6 months after the last dose of chemotherapy. During the Post Chemotherapy Follow-up Period, participants will be evaluated for CIPN using PROs and ClinROs. NF-L will also be measured at the beginning and at the end of the Post-Chemotherapy Follow-up Period. PROs will be assessed electronically on a monthly basis.

Clinical Study Identifier: NCT03997981

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VCU Medical Center

Richmond, VA United States
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