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Symptoms
Delirium
Depression
Fatigue
Pain
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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:
- 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.
- 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.
- At the end of Week 4, the hemoglobin level must be obtained
prior to administering Procrit.
- 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.
- Patients will continue on Procrit for a maximum of 16 weeks.
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