A Phase III Clinical Trial of PROCRIT (Epoetin Alfa) Versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer
The purpose of this study is to determine whether it is possible to measure temporary difficulty with thinking and/or short-term memory in women who are receiving chemotherapy for early stage breast cancer and to determine whether or not treatment with PROCRITÂ® will help decrease any problems with thinking or short-term memory that chemotherapy may cause.
Quality of Life
Drug: epoetin alfa
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase III Clinical Trial of PROCRIT (Epoetin Alfa) Versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer|
- To assess the effect of PROCRIT® on impairment of cognitive and executive function
- To assess the effect of PROCRIT® on severe fatigue, quality of life and mood. Hemoglobin (Hg) Responders were those patients who did not require transfusion during the treatment phase and who demonstrated a > or = 2 g/dL increase in Hg or Hg of 12 g/dL.
|Study Start Date:||December 2002|
|Study Completion Date:||June 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246597
|Study Director:||Ortho Biotech Products, L.P. Clinical Trial||Ortho Biotech Products, L.P.|