A Phase III Clinical Trial of PROCRIT (Epoetin Alfa) Versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer
Studies of the effect of erythropoietin on rat and mouse brain suggests a neuroprotective
and cognitive-enhancing effect of this hormone. The objective of this study was to quantify
and compare the incidence of chemotherapy-related impairment of cognitive and executive
function in breast cancer patients randomized to receive PROCRIT versus placebo while
receiving adjuvant anthracycline-based chemotherapy with or without a Taxane and to evaluate
the effect of PROCRIT® on the incidence of asthenia (severe fatigue), quality of life (QoL),
and mood. Patients received study medication injections (40,000 units) under their skin once
every week for 12 to 24 weeks of chemotherapy. Doses were adjusted depending on the
patients' hemoglobin level up to a maximum of 60,000 units.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
To assess the effect of PROCRIT® on impairment of cognitive and executive function
Ortho Biotech Products, L.P. Clinical Trial
Ortho Biotech Products, L.P.
United States: Institutional Review Board