Anemia - Cancer Related Clinical Trial
Official title:
Prediction of Response to Erythropoietin Treatment in Cancer Related Anemia Patients Receiving Chemotherapy
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).
| Status | Terminated |
| Enrollment | 33 |
| Est. completion date | February 2012 |
| Est. primary completion date | February 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Janssen-Cilag Ltd.,Thailand | Mahidol University |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | Serum Hematocrit Level | Hematocrit is the amount of red blood cells in the blood. | Baseline, Week 1, Week 2, Week 4 and Week 8 | No |
| Secondary | Reticulocyte Count | Reticulocytes are immature red blood cells. | Baseline, Week 1, Week 2, Week 4 and Week 8 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |