Randomized Double Blind, Placebo Controlled Trial of Neuroprotective Effects of Epoetin Alfa (Procrit (Trademark)) in Patients Receiving Adjuvant Chemotherapy for Breast Cancer

摘要

Cognitive deficits (e.g. problems with memory and concentration) are common during and after adjuvant breast cancer chemotherapy, but the pathophysiology of these phenomena is unknown. Cognitive impairment can, certainly, limit a patient's quality of life. The treatment of the cognitive dysfunction has not been investigated. 130 water activation using Positron Emission Tomography (PET) scan yields patterns of blood flow to brain regions used in specific cognitive skills. Studies with erythropoietin (EPO) on rat and mouse brains suggest that it protects the brain from ischemia, concussive brain injury, and toxin exposure and enhances cognitive function. We hypothesize that 130 water PET scan along with neuropsychological tests can evaluate the effectiveness of EPO as a treatment for cognitive dysfunction and identify the pathophysiology of cognitive dysfunction in patients receiving. Patients with early stage breast cancer who are candidates for adjuvant chemotherapy will undergo 150 water PET scans at baseline to measure the differences in regional blood flow of the brain during working memory. Specific neuropsychological tests will be done to study the attention, speeded processing, memory, and executive functions outside of the scanner. When the patients start treatment with AC they will be randomized into two groups. One group will receive weekly injections with EPO and the other group will receive placebo. PET scans and neuropsychological studies will be repeated in these two groups at the end of 4 cycles of AC. The trial opened to accrual in April 2003 and there are currently two patients enrolled.