Impact of Human Recombinant Erithoropoietin (ior EPOCIM) in cancer patients with post Chemo and Radiotherapy induced anemia.
Phase 4
- Conditions
- Anemia secondary to chemo and/or radiotherapy.
- Registration Number
- RPCEC00000079
- Lead Sponsor
- Center of Molecular Immunology(CIM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 338
Inclusion Criteria
1.Patients that fulfill the diagnostic criteria. 2.Patients with cytological and/or histological diagnosis of cancer in any localization that are receiving chemo and/or radiotherapy. 3.Patient with age over or equal to 18 years. 4.Patients of both sexes.
Exclusion Criteria
1.Patients with known hypersensitivity to products derived from superior cells or hypersensitivity to human albumin. 2.Pregnant or breastfeeding patients. 3.Patients with active hemorrhage or hemolysis. 4.Patients with non controlled arterial hypertension.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Value of Hemoglobin in g / l at the beginning of treatment and at the 8th week.
- Secondary Outcome Measures
Name Time Method Recovery time of normal hemoglobin values,at 8 weeks of treatment. Adverse event(AE),description of adverse events,measurement time:8 weeks. Duration of adverse event, in minutes or days, measurement time: 8 weeks. Intensity of adverse events: Light, Moderate, Severe or less serious according to the MOS, measurement time: 8 weeks. Causal relationship: Causation remote,Causation Possible,Probable Causation, Causation very likely, measurement time: 8 weeks. Indicators of Quality of Life, will assess the improvement of the parameters of quality of life through Fact-An Inquiry, measurement time: 8 weeks Number of transfusions received during the previous 2 months and weekly during treatment