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

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

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

Secondary indentifying numbers:

IIC RD-092

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology(CIM)

Source(s) of monetary or material support:

Goverment found

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

24/10/2004

Reference number:

1212121212

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Alicia Rodríguez Abascal,MD.First grade specialist in Oncology.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana City,Hermanos Ameijeiras Clinical Surgical Hospital.Oncology Service and Hematology Service ,Jorge Luís Soriano,MD.Second degree specialist in Oncology. Havana City,National Institute of Hematology and Immunology,Carlos Hernández Padrón,MD.Second degree specialist in Hematology. Havana City,Medical Surgical Research Center(CIMEQ),MD.Mario Wilford de Leon,Second degree specialist in Hematology. Villa Clara, Celestino Hernández Robau Hospital,MD.Ana de la Torre Santos,Second degree specialist in Oncology. Holguín,Vladimir Ilich Lenin Province Teaching Hospital,Rene Díaz Santos,MD.First degree specialist in Oncology. Santiago de Cuba, Conrado Benítez Oncology Hospital,Demetrio Segura López, MD. First degree specialist in Oncology. Santiago of Cuba, General Hospital , Marisol Rodríguez Brunet,MD.First degree specialist in Hematology, Beatríz de la Uz Ruezga,MD.First degree specialist in Hematology.

Research ethics committees:

Havana City,National Institute of Hematology and Immunology,November 5,2004. Havana City,Hermanos Ameijeiras Clinical Surgical Hospital,July 5,2004. Havana City,Center For Surgical Research,July 1,2004. Havana City,National Institute of Oncology and Radiobiology,November 8,2004. Villa Clara,Dr.Celestino Hernandez Robau Universitary Hospital,April 21,2004. Holguin,Vladimir Ilich Lenin Hospital,July 21,2004. General Teaching Hospital of Santiago de Cuba,September 9,2004. Santiago of Cuba,Conrado Benitez Garcia Oncology Hospital,July 14,2004.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

25/10/2004

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18

Maximum age:

none

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Non-randomized controlled trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

4

Target sample size:

338

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

MD.Patricia

Last Name:

Piedra

Affiliation:

CIMAB S.A

Postal Address:

206 No.1926,e/19 and 21,Atabey,Playa

City:

Havana City

País:

Cuba

Zip Code:

11600

Telephone:

(537)271-50-57 Ext.111

Email :

patrip@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

MD.Patricia

Last Name:

Piedra

Affiliation:

CIMAB S.A

Postal Address:

206 No.1926,e/19 and 21,Atabey,Playa

City:

Havana City

País:

Cuba

Zip Code:

11600

Telephone:

(537)271-50-57 Ext.111

Email :

patrip@cim.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000079

Date of Registration in Primary Registry:

2009-07-03

Record Verification Date:

2009-06-26 20:00

Link to the spanish version:

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

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