An Observational Study to Predict the Response of Erythropoietin Treatment in Participants With Cancer Related Anemia Receiving Chemotherapy
|ClinicalTrials.gov Identifier: NCT01736215|
Recruitment Status : Terminated (This study was terminated regarding to slow enrollment.)
First Posted : November 29, 2012
Results First Posted : May 30, 2013
Last Update Posted : April 29, 2014
|Condition or disease||Intervention/treatment|
|Anemia - Cancer Related||Drug: Erythropoietin: Observational study|
|Study Type :||Observational|
|Actual Enrollment :||33 participants|
|Official Title:||Prediction of Response to Erythropoietin Treatment in Cancer Related Anemia Patients Receiving Chemotherapy|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Participants with cancer related anemia
Participants with cancer related anemia receiving chemotherapy will be observed for response to erythropoietin treatment.
Drug: Erythropoietin: Observational study
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.
- Percentage of Participants With Response to Erythropoietin Treatment [ Time Frame: 8 weeks ]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.
- Number of Participants With Serum Erythropoietin (EPO) Level (EPO Less Than or Equal to 45.2 or EPO Greater Than 45.3) [ Time Frame: Baseline ]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.
- Number of Participants With C-Reactive Protein (CRP) Level Less Than or Equal to 10.3 or Greater Than 10.4 [ Time Frame: Baseline ]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.
- Serum Hemoglobin Level [ Time Frame: Baseline, Week 1, Week 2, Week 4 and Week 8 ]Hemoglobin is defined as a substance that carries oxygen and gives blood its red color.
- Serum Hematocrit Level [ Time Frame: Baseline, Week 1, Week 2, Week 4 and Week 8 ]Hematocrit is the amount of red blood cells in the blood.
- Reticulocyte Count [ Time Frame: Baseline, Week 1, Week 2, Week 4 and Week 8 ]Reticulocytes are immature red blood cells.
- Serum Ferritin Level [ Time Frame: Baseline, Week 1 and Week 2 ]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.
- Serum Iron Level [ Time Frame: Baseline, Week 1 and Week 2 ]Serum iron is a test that measures the amount of iron in the blood which is bound to transferrin.
- Transferring Iron Binding Capacity (TIBC) [ Time Frame: Baseline, Week 1 and Week 2 ]TIBC is a medical laboratory test that measures the blood's capacity to bind iron with transferrin.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736215
|Chiang Mai, Thailand|
|Khon Kaen, Thailand|
|Study Director:||Janssen-Cilag Ltd.,Thailand Clinical Trial||Janssen-Cilag Ltd.,Thailand|