An observational study in Anemia - Cancer Related, sponsored by Janssen-Cilag Ltd.,Thailand. Terminated at 3 sites in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-29.
Sponsored by Janssen-Cilag Ltd.,Thailand · Observational
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.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 33 is below the median of 200 across 326 observational studies indexed under Anemia.
Browse Anemia studies →Janssen-Cilag Ltd.,Thailand is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participant with cancer related anemia receiving chemotherapy will be observed for response to erythropoietin treatment.
Exclusion Criteria:
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
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
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
| Milestone | Participants With Cancer Related Anemia |
|---|---|
| Started | 33 |
| Treated | 25 |
| Completed | 19 |
| Not completed | 14 |
| Withdrew: Early termination of erythropoietin use | 1 |
| Withdrew: Adverse event | 4 |
| Withdrew: Progressive disease stop chemotherapy | 1 |
| Withdrew: Insufficient data to perform analysis | 8 |
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.
| Percentage of participants | Participants With Cancer Related Anemia |
|---|---|
| Percentage of Participants With Response to Erythropoietin Treatment | 52.63 |
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.
| Participants | Participants With Cancer Related Anemia |
|---|---|
| EPO level less than or equal to 45.2 | 12 ± 59.05 |
| EPO level greater than 45.3 | 13 |
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.
| Participants | Participants With Cancer Related Anemia |
|---|---|
| CRP less than or equal to 10.3 | 13 ± 27.22 |
| CRP greater than 10.4 | 12 |
Hemoglobin is defined as a substance that carries oxygen and gives blood its red color.
| Gram per deciliter (g per dl) | Participants With Cancer Related Anemia |
|---|---|
| Baseline (n=19) | 9.96 ± 0.93 |
| Week 1 (n=18) | 9.94 ± 0.94 |
| Week 2 (n=18) | 10.00 ± 1.06 |
| Week 4 (n=18) | 10.64 ± 1.59 |
| Week 8 (n=7) | 10.43 ± 1.49 |
Hematocrit is the amount of red blood cells in the blood.
| Percentage of red blood cells | Participants With Cancer Related Anemia |
|---|---|
| Baseline (n=19) | 30.75 ± 3.34 |
| Week 1 (n=18) | 30.59 ± 2.93 |
| Week 2 (n=18) | 30.76 ± 3.17 |
| Week 4 (n=18) | 33.19 ± 5.41 |
| Week 8 (n=7) | 33.01 ± 5.09 |
Reticulocytes are immature red blood cells.
| Nanogram per liter | Participants With Cancer Related Anemia |
|---|---|
| Baseline (n=18) | 92.33 ± 58.27 |
| Week 1 (n=17) | 64.81 ± 83.90 |
| Week 2 (n=16) | 200.74 ± 110.37 |
| Week 4 (n=17) | 120.68 ± 118.18 |
| Week 8 (n=7) | 111.74 ± 70.37 |
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.
| Microgram per liter | Participants With Cancer Related Anemia |
|---|---|
| Baseline (n=19) | 807.28 ± 746.84 |
| Week 1 (n=18) | 870.28 ± 638.48 |
| Week 2 (n=18) | 685.11 ± 565.32 |
Serum iron is a test that measures the amount of iron in the blood which is bound to transferrin.
| Microgram per deciliter (Mcg per dl) | Participants With Cancer Related Anemia |
|---|---|
| Baseline | 66.06 ± 65.04 |
| Week 1 | 89.22 ± 74.35 |
| Week 2 | 53.06 ± 31.74 |
TIBC is a medical laboratory test that measures the blood's capacity to bind iron with transferrin.
| Mcg per dl | Participants With Cancer Related Anemia |
|---|---|
| Baseline (n=19) | 275.26 ± 54.62 |
| Week 1 (n=18) | 281.39 ± 54.75 |
| Week 2 (n=18) | 288.17 ± 65.39 |
Collected over Baseline up to Week 8. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With Cancer Related Anemia | — | 4/25 (16%) | 18/25 (72%) |
| Event | Participants With Cancer Related Anemia |
|---|---|
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/25 |
| VomittingGastrointestinal disorders | 1/25 |
| Abdominal pain upperGastrointestinal disorders | 1/25 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/25 |
| Urinary Tract InfectionInfections and infestations | 1/25 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/25 |
| Event | Participants With Cancer Related Anemia |
|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 6/25 |
| LeukopeniaBlood and lymphatic system disorders | 4/25 |
| DyspepsiaGastrointestinal disorders | 2/25 |
| Chest painRespiratory, thoracic and mediastinal disorders | 2/25 |
| Neuropathy peripheralNervous system disorders | 2/25 |
| MyalgiaMusculoskeletal and connective tissue disorders | 2/25 |
| FatigueGeneral disorders | 2/25 |
| Decreased appetiteMetabolism and nutrition disorders | 2/25 |
| Skin rashSkin and subcutaneous tissue disorders | 1/25 |
| DizzinessNervous system disorders | 1/25 |
Number of participants analyzed for this baseline characteristic included all the participants who received erythropoietin treatment and had sufficient data to perform statistical evaluation.
| Age, Continuous(Years) | Participants With Cancer Related Anemia |
|---|---|
| Mean | 59.20 ± 8.63 |
| Sex: Female, Male(Participants) | Participants With Cancer Related Anemia |
|---|---|
| Female | 8 |
| Male | 17 |
This study is terminated, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Janssen-Cilag Ltd.,Thailand