Epoetin Alfa in Treating Fatigue in Patients With Advanced Solid Tumors Who Are Not Receiving Chemotherapy
- Conditions
- Unspecified Adult Solid Tumor, Protocol SpecificFatigue
- Registration Number
- NCT00052221
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method