Chang, J., Couture, F.A., Young, S.D., Lau, C.Y., & McWatters, K.L. (2004). Weekly administration of epoetin alfa improves cognition and quality of life in patients with breast cancer receiving chemotherapy. Supportive Cancer Therapy, 2, 52–58.

DOI Link

Study Purpose

The study's primary aim was to evaluate the effect of epoetin alfa on changes in quality of life and utility scale scores at week 12. Its secondary aim was to evaluate transfusion reduction and hemoglobulin level increase.

Intervention Characteristics/Basic Study Process

Participants were screened at the initiation of chemotherapy with hemoglobin (Hgb) levels ≤ 15.0 grams per deciliter (g/dL). Randomization occurred when the Hgb level was decreased to 12.0 g/dL. They received 40,000 IU of erythropoietin subcutaneously each week for 16 weeks or for 4 weeks after the completion of chemotherapy, whichever was longer (the maximum amount of time participants could receive erythropoietin was 28 weeks).

Sample Characteristics

  • All participants were female and had breast cancer. 
  • The number of participants was 354.
  • There were 176 participants in the treatment gruop and 178 in the control group.
  • The average participant age in the treatment group was 50.4 years, with a range of 27–85.
  • The average participants age in the control group was 50.1 years, with a range of 27–85.

 

Setting

This multi-site study was conducted in Canada. 

Study Design

The study was a phrase III, randomized, open-label, multi-center trial. 

Measurement Instruments/Methods

  • The Health Utilities Index Mark (HUI) measured eight components of quality of life, including cognition.
  • The Functional Assessment of Cancer Therapy (FACT) - Anemia and Fatigue measured cancer-related quality of life specific to symptoms of anemia and fatigue.
  • The Cancer Linear Analog Scale (CLAS) measured quality of life.
  • The EuroQol 5-Dimension (EQ-5D) is a linear analog scale of 0–100, with 100 representing the best imaginable health. It is described as the use of a thermometer, known as a feeling thermometer.

Results

Based on the subscale HUI survey, significant improvement in cognition (p = 0.02) was found in participants who received erythropoietin.

Conclusions

  • Improvement in cognition was based on a subjective, not objective, measurement.
  • Cognitive improvement may be independent of hematologic change, as it was not correlated with changes in Hgb level.

Limitations

No objective measure for cognitive function was used.