Spots Global Cancer Trial Database for Epoetin Alfa in Treating Fatigue in Patients With Advanced Solid Tumors Who Are Not Receiving Chemotherapy

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Trial Identification

Brief Title: Epoetin Alfa in Treating Fatigue in Patients With Advanced Solid Tumors Who Are Not Receiving Chemotherapy

Official Title: A Placebo Controlled Trial Of Short-Term, High-Dose Epoetin Alfa In Advanced Cancer Outpatients With Mild Fatigue

Study ID: NCT00052221

Conditions

Fatigue

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Epoetin alfa

Placebo

Study Description

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.