An Observational Study to Predict the Response of Erythropoietin Treatment in Participants With Cancer Related Anemia Receiving Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to evaluate the predictors of response to erythropoietin (hormone secreted by kidney that helps in formation of red blood cells in bone marrow) treatment in participants with cancer (abnormal tissue that grows and spreads in the body until it kills) related anemia (decreased number of red blood cells), receiving chemotherapy (treatment of cancer using drugs).

Detailed Description
-----------------
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.

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

Conditions
-----------------
Anemia - Cancer Related

Intervention / Treatment
-----------------
* Drug: Erythropoietin: Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with cancer related anemia<br>Participants with cancer related anemia receiving chemotherapy will be observed for response to erythropoietin treatment. | Drug: Erythropoietin: Observational study<br>* This is an observational study. Participants receiving erythropoietin (dosage and regimen will comply with Thai Food and Drug Administration approval package insert) will be observed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Response to Erythropoietin Treatment | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Serum Erythropoietin (EPO) Level (EPO Less Than or Equal to 45.2 or EPO Greater Than 45.3) | EPO is a hormone secreted by kidney that helps in formation of red blood cells in bone marrow. Number of participants with EPO level less than or equal to 45.2 or greater than 45.3 were observed. | Baseline | 
| Number of Participants With C-Reactive Protein (CRP) Level Less Than or Equal to 10.3 or Greater Than 10.4 | CRP is a acute serum protein released from liver. It is associated with low hemoglobin or erythropoeitin resistance. Number of participants with CRP level less than or equal to 10.3 or greater than 10.4 were observed. | Baseline | 
| Serum Hemoglobin Level | Hemoglobin is defined as a substance that carries oxygen and gives blood its red color. | Baseline, Week 1, Week 2, Week 4 and Week 8 | 
| Serum Hematocrit Level | Hematocrit is the amount of red blood cells in the blood. | Baseline, Week 1, Week 2, Week 4 and Week 8 | 
| Reticulocyte Count | Reticulocytes are immature red blood cells. | Baseline, Week 1, Week 2, Week 4 and Week 8 | 
| Serum Ferritin Level | Serum ferritin is the amount of ferritin in a participant's blood. Ferritin is a protein that stores iron and allows the body to use iron. | Baseline, Week 1 and Week 2 | 
| Serum Iron Level | Serum iron is a test that measures the amount of iron in the blood which is bound to transferrin. | Baseline, Week 1 and Week 2 | 
| Transferring Iron Binding Capacity (TIBC) | TIBC is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. | Baseline, Week 1 and Week 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemia - cancer related, Eprex (Erythropoietin alfa)