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Oncology Symptom Control Research (OSCR):  Procrit versus standard care in treatment of fatigue associated with chemotherapy-induced anemia

Research Study Objectives:
  • To enhance the recognition and treatment of fatigue and anemia in cancer patients through screening and intervention algorithm.
  • Inclusion Criteria:
  • Undergoing chemotherapy treatment for a non-myeloid malignancy Hemoglobin of < 11.0 g/dL
  • Life expectancy of > 6 months Age 18+
  • Understand and give informed consent
  • Endorse the Zung Fatigue item # 10 "I get tired for no reason" at least "some of the time"
  • Exclusion Criteria:
  • Uncontrolled hypertension
  • Known sensitivity to mammalian cell-derived products
  • Anemia due to factors other than cancer/chemotherapy (i.e., iron or folate deficiencies, hemolysis, or gastrointestinal bleeding) Candidate for bone marrow transplant Received prior Epoetin Alfa therapy
  • Scored above the moderate range for depressive symptoms on the Zung.
  • Procedure:

    1. Prior to initiation of the study, physicians and nurses at study sites will be asked to complete a knowledge and attitudes survey regarding fatigue and chemotherapy- induced anemia.
    2. The patients will then be randomized to Eopetin Alfa (Procrit) or standard care. The starting dose of Procrit is 40,000 Units s.c. qwk.
    3. At the end of Week 4, the hemoglobin level must be obtained prior to administering Procrit.
    4. If, at the end of Week 4, (after 4 once weekly doses of Procrit), the hemoglobin does not increase by >1.0 g/dL, the dose of Procrit is to be increased to 60,000 Units s.c. qwk starting with the Week 5 (fifth weekly) dose.
    5. Patients will continue on Procrit for a maximum of 16 weeks.