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Prediction of Response to Erythropoietin Treatment in Cancer Related Anemia Patients Receiving Chemotherapy


Phase 4
18 Years
N/A
Not Enrolling
Both
Anemia - Cancer Related

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Trial Information

Prediction of Response to Erythropoietin Treatment in Cancer Related Anemia Patients Receiving Chemotherapy


This is an observational, prospective (study following participants forward in time),
multi-center (study conducted in more than 1 center) study to identify the predictive
factors that will effectively predict the response to erythropoietin treatment in cancer
related anemia participants receiving chemotherapy. The entire duration of study will be
approximately 1 year. Participants will primarily be evaluated for achieving at least 1 gram
per deciliter (g per dl) rise in hemoglobin (substance that carries oxygen and gives blood
its red color) level after receiving erythropoietin treatment based on National
Comprehensive Cancer Institute (NCCN) V3.2009 practice guideline criteria. Response to
erythropoietin treatment will also be predicted using other independent hematological
(related to blood) factors like C-reactive protein (CRP - is an acute serum protein released
from liver). It is associated with low hemoglobin [substance that carries oxygen and gives
blood its red color] or erythropoietin [hormone secreted by kidney that helps in formation
of red blood cells in bone marrow] resistance), erythropoietin (EPO), hemoglobin, hematocrit
(amount of red blood cells in blood), reticulocyte (immature red blood cells) count,
ferritin (a protein that stores iron and allows the body to use iron), serum iron (iron is
in the blood which is bound to transferrin) and transferring iron binding capacity (TIBC),
level. Number of blood transfusions and participants' safety will be monitored throughout
the study.


Inclusion Criteria:



- Participants with non-hematologic malignancy (cancer or other progressively enlarging
and spreading tumor, usually fatal if not successfully treated)

- Participants with life expectancy of at least 6 months based on the Investigator's
clinical judgment

- Participants receiving chemotherapy

- Participants having indication and planning to receiving erythropoietin (dosage and
regimen should comply with Thai FDA approval package insert)

- Participants who have given consent form

Exclusion Criteria:

- Participants with anemia due to other factors (i.e., iron, B12 or folate
deficiencies, hemolysis [breakdown in red blood cells], gastrointestinal bleeding, or
any active bleeding)

- Participants with previous history of erythropoietin treatment

- Participants who have received blood transfusion within 1 month before starting
erythropoietin therapy

- Pregnant or breast-feeding female participants

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Percentage of Participants With Response to Erythropoietin Treatment

Outcome Description:

Responders of erythropoietin treatment were defined as participants who achieved at least 1 gram per deciliter (g per dl) rise from Baseline in hemoglobin level during within 4-8 weeks or participants who achieved 12 g per dl hemoglobin level at anytime during the study evaluation period (about 8 weeks of follow-up, hemoglobin level reached to 12 g per dl or participants who received blood transfusion at any time of study period) based on National Comprehensive Cancer Institute (NCCN) V3.2009 practice guideline criteria.

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Janssen-Cilag Ltd.,Thailand Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen-Cilag Ltd.,Thailand

Authority:

Chulalongkorn: Chulalongkorn Ethics Committee

Study ID:

CR016558

NCT ID:

NCT01736215

Start Date:

November 2010

Completion Date:

February 2012

Related Keywords:

  • Anemia - Cancer Related
  • Anemia - cancer related
  • Eprex (Erythropoietin alfa)
  • Anemia

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