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).
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.
Study Type
OBSERVATIONAL
Enrollment
33
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.
Unnamed facility
Bangkok, Thailand
Unnamed facility
Chiang Mai, Thailand
Unnamed facility
Khon Kaen, Thailand
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.
Time frame: 8 weeks
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.
Time frame: 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.
Time frame: Baseline
Serum Hemoglobin Level
Hemoglobin is defined as a substance that carries oxygen and gives blood its red color.
Time frame: Baseline, Week 1, Week 2, Week 4 and Week 8
Serum Hematocrit Level
Hematocrit is the amount of red blood cells in the blood.
Time frame: Baseline, Week 1, Week 2, Week 4 and Week 8
Reticulocyte Count
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Reticulocytes are immature red blood cells.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 1 and Week 2