Clinical trial · Interventional
A Study of the Effectiveness and Safety of Treatment With Epoetin Alfa on Hemoglobin Levels, Red Blood Cell Transfusions, and Quality of Life in Patients With Cancer Receiving Platinum-containing Chemotherapy
An Open-label, Randomized Study to Evaluate the Effect of Early Treatment of Anemia With Epoetin Alfa on Hemoglobin, the Incidence of Blood Transfusions and Quality of Life in Patients Receiving Platinum-containing Chemotherapy
- 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)
The purpose of this study is to compare the effectiveness of early treatment of anemia with epoetin alfa (a glycoprotein that stimulates red blood cell production) or best standard anemia care on the need for blood transfusions, tumor response, anemia and quality of life in patients with cancer receiving platinum-containing chemotherapy.
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 |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Neoplasm | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epoetin alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of patients who receive an allogenic red blood cell transfusion during the study, during each chemotherapy cycle, and at 4 weeks after the last administration of chemotherapy
Secondary outcomes (1)
- measure
- Number of units transfused during each chemotherapy cycle; change in quality of life; change in hemoglobin level; relationship between change in hemoglobin and quality of life; tumor response; patient survival up to 12 months after the end of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients having a confirmed diagnosis of cancer and are planned to receive platinum chemotherapy with a minimum of 8 weeks on study and a maximum of 6 or 12 cycles * Eastern Cooperative Oncology Group (a scale used by researchers to represent the level of activity that a patient is capable of) score of 0 (able to carry out all normal activity without restriction) to 3 (capable of only limited self-care, confined to bed or chair \>50% of waking hours) * life expectancy of \>=5 months * have a hemoglobin value of \<=7.5 grams per deciliter at any time during or prior to chemotherapy Exclusion Criteria: * Patients having clinically significant disease/dysfunction of the pulmonary, cardiovascular, endocrine, neurological, gastrointestinal, or genitourinary systems that is not due to cancer or chemotherapy (this disease/dysfunction is only an exclusion criterion if it causes an expected early withdrawal from the study) * uncontrolled high blood pressure * history of seizures * untreated iron, folate, or vitamin B12 deficiency * received androgen (e.g., testosterone) therapy within 2 months of study entry, had a major illness within 7 days of study entry, or a major infection within 1 month of study entry
References
Publications (1)
- RESULTSavonije JH, van Groeningen CJ, van Bochove A, Honkoop AH, van Felius CL, Wormhoudt LW, Giaccone G. Effects of early intervention with epoetin alfa on transfusion requirement, hemoglobin level and survival during platinum-based chemotherapy: Results of a multicenter randomised controlled trial. Eur J Cancer. 2005 Jul;41(11):1560-9. doi: 10.1016/j.ejca.2005.03.024. PMID 15953714