Clinical trial · Interventional
Epoetin Alfa in Treating Fatigue in Patients With Advanced Solid Tumors Who Are Not Receiving Chemotherapy
A Placebo Controlled Trial Of Short-Term, High-Dose Epoetin Alfa In Advanced Cancer Outpatients With Mild Fatigue
NCT00052221CI-TRIAL-00035688withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epoetin alfa | Biological | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I: Epoetin Alfa
- description
- Epoetin alfa subcutaneously (SC) once weekly for 6 weeks
- interventionNames
- Biological: Epoetin alfa
- type
- PLACEBO_COMPARATOR
- label
- Arm II: Placebo
- description
- Placebo subcutaneously (SC) once weekly for 6 weeks
- interventionNames
- Other: Placebo
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of stage III or IV invasive non-myeloid malignancy * Not currently hospitalized * At least somewhat bothered by fatigue based on self-report * No significant psychological distress indicated by total score of 6 or more on questions 1 and 2 of the Three-Question Screening Survey (3QSS) * No score less than 2 on question 3 of 3QSS indicating low level of fatigue within the past week * No uncontrolled brain metastases or leptomeningeal involvement PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Eastern Cooperative Oncology Group (ECOG) 0-3 Life expectancy: * At least 12 weeks Hematopoietic: * Hemoglobin at least 8.5 g/dL but no greater than 11 g/dL * No anemia due to factors other than cancer or chemotherapy (e.g., iron or folate deficiency, hemolysis, or bleeding) * No prior or concurrent hematological disease Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No uncontrolled hypertension (diastolic blood pressure greater than 100 mm Hg or systolic blood pressure greater than 200 mm Hg) * No significant uncontrolled concurrent cardiovascular disease or dysfunction not attributable to malignancy or chemotherapy * No history of deep-vein thrombosis Pulmonary: * No significant uncontrolled concurrent pulmonary disease or dysfunction not attributable to malignancy or chemotherapy Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 3 months after study participation * Able to understand and complete self-report symptom assessment forms in English * No serious concurrent infection * No known hypersensitivity to mammalian cell-derived products or human albumin * No uncontrolled seizures * No significant uncontrolled concurrent endocrine, neurologic, gastrointestinal, or genitourinary system disease or dysfunction not attributable to malignancy or chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy: * See Chemotherapy * More than 4 weeks since prior biologic therapy (e.g., interferon or interleukin-2) * More than 2 months since prior red blood cells (RBC) transfusion * More than 1 month since prior epoetin alfa or investigational forms of epoetin alfa (e.g., gene-activated, novel erythropoiesis-stimulating protein) * Concurrent non-myelosuppressive therapy (e.g., monoclonal antibody infusions, antiangiogenesis inhibitors, or signal transduction inhibitors) allowed * No other concurrent biologic therapy Chemotherapy: * No prior high-dose chemotherapy (e.g., with bone marrow or stem cell transplantation) * More than 4 weeks since prior chemotherapy * No concurrent chemotherapy Endocrine therapy: * Concurrent hormonal therapy allowed (e.g., luteinizing hormone-releasing hormone agonists or tamoxifen) Radiotherapy: * More than 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.