Anemia - Cancer Related
Conditions
Keywords
Anemia - cancer related, Eprex (Erythropoietin alfa)
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.
Interventions
DRUGErythropoietin: 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.
Sponsors
Mahidol University
Janssen-Cilag Ltd.,Thailand
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Response to Erythropoietin Treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With C-Reactive Protein (CRP) Level Less Than or Equal to 10.3 or Greater Than 10.4 | 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 | 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 | Baseline, Week 1, Week 2, Week 4 and Week 8 | Hematocrit is the amount of red blood cells in the blood. |
| Number of Participants With Serum Erythropoietin (EPO) Level (EPO Less Than or Equal to 45.2 or EPO Greater Than 45.3) | 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. |
| Serum Ferritin Level | 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 | 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) | Baseline, Week 1 and Week 2 | TIBC is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. |
| Reticulocyte Count | Baseline, Week 1, Week 2, Week 4 and Week 8 | Reticulocytes are immature red blood cells. |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants With Cancer Related Anemia Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Early termination of erythropoietin use | 1 |
| Overall Study | Insufficient data to perform analysis | 8 |
| Overall Study | Progressive disease stop chemotherapy | 1 |
Baseline characteristics
| Characteristic | Participants With Cancer Related Anemia |
|---|---|
| Age, Continuous | 59.20 Years STANDARD_DEVIATION 8.63 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 25 |
| serious Total, serious adverse events | 4 / 25 |
Outcome results
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.
Time frame: 8 weeks
Population: Participants who received erythropoietin treatment and had the data available at least on Baseline and at the end of study evaluation period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Cancer Related Anemia | Percentage of Participants With Response to Erythropoietin Treatment | 52.63 Percentage of participants |
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.
Time frame: Baseline
Population: Participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation were analyzed.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Participants With Cancer Related Anemia | Number of Participants With C-Reactive Protein (CRP) Level Less Than or Equal to 10.3 or Greater Than 10.4 | CRP less than or equal to 10.3 | 13 Participants | 27.22 |
| Participants With Cancer Related Anemia | Number of Participants With C-Reactive Protein (CRP) Level Less Than or Equal to 10.3 or Greater Than 10.4 | CRP greater than 10.4 | 12 Participants | — |
p-value: 0.0595% CI: [0.016, 0.999]Regression, Logistic
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.
Time frame: Baseline
Population: Participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation were analyzed.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Participants With Cancer Related Anemia | Number of Participants With Serum Erythropoietin (EPO) Level (EPO Less Than or Equal to 45.2 or EPO Greater Than 45.3) | EPO level less than or equal to 45.2 | 12 Participants | 59.05 |
| Participants With Cancer Related Anemia | Number of Participants With Serum Erythropoietin (EPO) Level (EPO Less Than or Equal to 45.2 or EPO Greater Than 45.3) | EPO level greater than 45.3 | 13 Participants | — |
p-value: 0.26695% CI: [0.052, 2.261]Regression, Logistic
Secondary
Reticulocyte Count
Reticulocytes are immature red blood cells.
Time frame: Baseline, Week 1, Week 2, Week 4 and Week 8
Population: Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'N' signifies participants who were evaluablated for this outcome measure and 'n' signifies participants who were evaluated for this outcome measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Cancer Related Anemia | Reticulocyte Count | Baseline (n=18) | 92.33 Nanogram per liter | Standard Deviation 58.27 |
| Participants With Cancer Related Anemia | Reticulocyte Count | Week 1 (n=17) | 64.81 Nanogram per liter | Standard Deviation 83.9 |
| Participants With Cancer Related Anemia | Reticulocyte Count | Week 2 (n=16) | 200.74 Nanogram per liter | Standard Deviation 110.37 |
| Participants With Cancer Related Anemia | Reticulocyte Count | Week 4 (n=17) | 120.68 Nanogram per liter | Standard Deviation 118.18 |
| Participants With Cancer Related Anemia | Reticulocyte Count | Week 8 (n=7) | 111.74 Nanogram per liter | Standard Deviation 70.37 |
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.
Time frame: Baseline, Week 1 and Week 2
Population: Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Cancer Related Anemia | Serum Ferritin Level | Baseline (n=19) | 807.28 Microgram per liter | Standard Deviation 746.84 |
| Participants With Cancer Related Anemia | Serum Ferritin Level | Week 1 (n=18) | 870.28 Microgram per liter | Standard Deviation 638.48 |
| Participants With Cancer Related Anemia | Serum Ferritin Level | Week 2 (n=18) | 685.11 Microgram per liter | Standard Deviation 565.32 |
Secondary
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
Population: Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Cancer Related Anemia | Serum Hematocrit Level | Baseline (n=19) | 30.75 Percentage of red blood cells | Standard Deviation 3.34 |
| Participants With Cancer Related Anemia | Serum Hematocrit Level | Week 1 (n=18) | 30.59 Percentage of red blood cells | Standard Deviation 2.93 |
| Participants With Cancer Related Anemia | Serum Hematocrit Level | Week 2 (n=18) | 30.76 Percentage of red blood cells | Standard Deviation 3.17 |
| Participants With Cancer Related Anemia | Serum Hematocrit Level | Week 4 (n=18) | 33.19 Percentage of red blood cells | Standard Deviation 5.41 |
| Participants With Cancer Related Anemia | Serum Hematocrit Level | Week 8 (n=7) | 33.01 Percentage of red blood cells | Standard Deviation 5.09 |
Secondary
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
Population: Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Cancer Related Anemia | Serum Hemoglobin Level | Baseline (n=19) | 9.96 Gram per deciliter (g per dl) | Standard Deviation 0.93 |
| Participants With Cancer Related Anemia | Serum Hemoglobin Level | Week 1 (n=18) | 9.94 Gram per deciliter (g per dl) | Standard Deviation 0.94 |
| Participants With Cancer Related Anemia | Serum Hemoglobin Level | Week 2 (n=18) | 10.00 Gram per deciliter (g per dl) | Standard Deviation 1.06 |
| Participants With Cancer Related Anemia | Serum Hemoglobin Level | Week 4 (n=18) | 10.64 Gram per deciliter (g per dl) | Standard Deviation 1.59 |
| Participants With Cancer Related Anemia | Serum Hemoglobin Level | Week 8 (n=7) | 10.43 Gram per deciliter (g per dl) | Standard Deviation 1.49 |
Secondary
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
Population: Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'N' signifies participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Cancer Related Anemia | Serum Iron Level | Baseline | 66.06 Microgram per deciliter (Mcg per dl) | Standard Deviation 65.04 |
| Participants With Cancer Related Anemia | Serum Iron Level | Week 1 | 89.22 Microgram per deciliter (Mcg per dl) | Standard Deviation 74.35 |
| Participants With Cancer Related Anemia | Serum Iron Level | Week 2 | 53.06 Microgram per deciliter (Mcg per dl) | Standard Deviation 31.74 |
Secondary
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
Population: Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Cancer Related Anemia | Transferring Iron Binding Capacity (TIBC) | Baseline (n=19) | 275.26 Mcg per dl | Standard Deviation 54.62 |
| Participants With Cancer Related Anemia | Transferring Iron Binding Capacity (TIBC) | Week 1 (n=18) | 281.39 Mcg per dl | Standard Deviation 54.75 |
| Participants With Cancer Related Anemia | Transferring Iron Binding Capacity (TIBC) | Week 2 (n=18) | 288.17 Mcg per dl | Standard Deviation 65.39 |