Epoetin Alfa in Treating Fatigue in Patients With Advanced Solid Tumors Who Are Not Receiving Chemotherapy
RATIONALE: Epoetin alfa may help improve energy levels and quality of life in patients who have advanced solid tumors.
PURPOSE: Randomized clinical trial to study the effectiveness of epoetin alfa in treating fatigue in patients who are not receiving chemotherapy for advanced solid tumors.
|Fatigue Unspecified Adult Solid Tumor, Protocol Specific||Biological: Epoetin alfa Other: Placebo|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
|Official Title:||A Placebo Controlled Trial Of Short-Term, High-Dose Epoetin Alfa In Advanced Cancer Outpatients With Mild Fatigue|
|Study Start Date:||May 2003|
|Study Completion Date:||December 2004|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
Experimental: Arm I: Epoetin Alfa
Epoetin alfa subcutaneously (SC) once weekly for 6 weeks
|Biological: Epoetin alfa|
Placebo Comparator: Arm II: Placebo
Placebo subcutaneously (SC) once weekly for 6 weeks
- 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 these patients.
- Correlate self-reported level of energy with other commonly occurring symptoms (e.g., pain, depression, anxiety, dyspnea, appetite disturbance, or sleep disturbance) in these patients.
- 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 these patients.
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 study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052221
|Study Chair:||Michael J. Fisch, MD, MPH, FACP||M.D. Anderson Cancer Center|