O’Shaughnessy, J.A. (2002). Effects of epoetin alfa on cognitive function, mood, asthenia, and quality of life in women with breast cancer undergoing adjuvant chemotherapy. Clinical Breast Cancer, 3(Suppl. 3), S116–S120.

The study was conducted to assess the feasibility of quantifying the effect of epoetin alfa in patients with breast cancer who were receiving adjuvant chemotherapy on asthenia, executive cognitive functioning, and quality of life. 

Participants were randomized to receive 40,000 units weekly of erythropoietin or a placebo. Erythropoietin or placebo administration began on day 1 of chemotherapy. Both the erythropoietin and placebo were then dose-escalated, with the goal of keeping Hgb levels between 12 g/dL and 14 g/dL. All assessments were administered prior to the start of chemotherapy, one week prior to cycle 4, and 6 months following the completion of chemotherapy.

• All participants were female and had breast cancer.
• The number of participants was 100.
• There were 51 participants in the treatment group and 49 in the control group.
• The median age of the treatment group was 53 years.
• All patients were treated with four cycles of doxorubicin and cyclophosphamide.
• All participants had a Karnofsky performance status of ≥ 70%.
• Individuals who had packed red blood cell transfusions within 14 days of study entry, clinically significant anemia (not defined), or uncontrolled or severe cardiovascular disease were excluded from the study.

The study's setting is unknown. 

The study utilized a longitudinal, double-blind, randomized, controlled design. 

• The Executive Interview (EXIT-25) measured executive function.
• The Clock Drawing Task (CLOX) measured executive function.
• The Functional Assessment of Cancer Therapy (FACT)-Anemia measured cancer-related quality of life specific to the symptom of anemia.
• The Karnofsky Performance Status scale (KPS) measured general well-being. Scores range from 0 (death) to 100 (perfect health with no complaints or signs of disease).
• Quality of life was measured by a validated linear analogue scale (LASA).
• The Profile of Mood States (POMS) was also utilized.

A significantly higher mean Hgb level in patients on erythropoietin treatment was reported (p < 0.001). However, there were no significant differences in cognitive function.

The study failed to demonstrate a difference in cognitive functioning between patients in the erythropoietin and placebo groups.

• The number of erythropoietin doses administered to the treatment group was unclear, which could influence study results.
• The CLOX test was determined to be an insensitive measure for detecting cognitive changes.
• There was a lack of alternate forms for cognitive tests, so practice effects may have influenced study outcomes.