Anemia secondary to chemo and/or radiotherapy.
Conditions
Interventions
EPOCIM(EPO):10 000 UI,3 times per week by subcutaneous route during 4-8 weeks. Increase allowed until 20 000 UI.
Sponsors
Center of Molecular Immunology(CIM)
No proceed
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Value of Hemoglobin in g / l at the beginning of treatment and at the 8th week. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Cuba
Contacts
Public ContactMD.Patricia Piedra
CIMAB S.A
Outcome results
None listed