Impact of Human Recombinant Erithoropoietin (ior EPOCIM) in cancer patients with post Chemo and Radiotherapy induced anemia.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000079
• Date of registration: 03/07/2009
• Primary sponsor: Center of Molecular Immunology(CIM)
• Public title: Impact of Human Recombinant Erithoropoietin (ior EPOCIM) in cancer patients with post Chemo and Radiotherapy induced anemia.
• Scientific title: Impact of Human Recombinant Erithoropoietin(ior EPOCIM)in cancer patients with post Chemo and Radiotherapy induced anemia.
• Date of first enrolment: 25/10/2004
• Target sample size: 338
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000079-En
• Study type: Interventional
• Study design: Randomization: Nonrandomized Trial Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: MD.Patricia Piedra
• Affiliation: CIMAB S.A

• Name: MD.Patricia Piedra
• Affiliation: CIMAB S.A

Key inclusion & exclusion 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: 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.

Age minimum: 18
Age maximum: none
Gender: Both

Health Condition(s) or Problem(s) studied

Anemia secondary to chemo and/or radiotherapy.

Intervention(s)

EPOCIM(EPO):10 000 UI,3 times per week by subcutaneous route during 4-8 weeks. Increase allowed until 20 000 UI.

Primary Outcome(s)

Value of Hemoglobin in g / l at the beginning of treatment and at the 8th week.

Secondary Outcome(s)

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

Secondary ID(s)

IIC RD-092

Source(s) of Monetary Support

Goverment found

Secondary Sponsor(s)

No proceed