A Placebo Controlled Trial Of Short-Term, High-Dose Epoetin Alfa In Advanced Cancer Outpatients With Mild Fatigue
- Determine the efficacy of epoetin alfa in treating fatigue in patients with advanced
solid tumors who are not receiving chemotherapy.
- Determine the efficacy of this drug on functional status and overall quality of life in
- Correlate self-reported level of energy with other commonly occurring symptoms (e.g.,
pain, depression, anxiety, dyspnea, appetite disturbance, or sleep disturbance) in
- Correlate anemia with other common symptoms in these patients.
- Determine the internal consistency of fatigue self-report using three single-item
measures of this symptom and the responsiveness of each item to change over time in
OUTLINE: This is a double-blind, placebo-controlled, randomized, multicenter study. Patients
are stratified according to participating center, ECOG performance status (0-1 vs 2-3), and
hemoglobin prior to study (10 mg/dL or less vs greater than10 mg/dL). Patients are
randomized to one of two treatment arms.
- Arm I: Patients receive epoetin alfa subcutaneously (SC) once weekly for 6 weeks.
- Arm II: Patients receive placebo SC once weekly for 6 weeks. Patients in either arm
that do not respond to therapy may receive an additional 6 weeks of open-label epoetin
alfa SC once weekly.
In both arms, quality of life and fatigue are assessed at baseline and at 3 and 6 weeks. If
patients receive an additional 6 weeks of therapy, quality of life and fatigue are also
assessed at 9 and 12 weeks.
PROJECTED ACCRUAL: A total of 128 patients (64 per treatment arm) will be accrued for this
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Michael J. Fisch, MD, MPH, FACP
M.D. Anderson Cancer Center
United States: Institutional Review Board