Trial Outcomes & Findings for An Observational Study to Predict the Response of Erythropoietin Treatment in Participants With Cancer Related Anemia Receiving Chemotherapy (NCT NCT01736215)
NCT ID: NCT01736215
Last Updated: 2014-04-29
Results Overview
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.
TERMINATED
33 participants
8 weeks
2014-04-29
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
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33
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Overall Study
Treated
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25
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Early termination of erythropoietin use
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1
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Overall Study
Adverse Event
|
4
|
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Overall Study
Progressive disease stop chemotherapy
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1
|
|
Overall Study
Insufficient data to perform analysis
|
8
|
Baseline Characteristics
An Observational Study to Predict the Response of Erythropoietin Treatment in Participants With Cancer Related Anemia Receiving Chemotherapy
Baseline characteristics by cohort
| Measure |
Participants With Cancer Related Anemia
n=25 Participants
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.
|
|---|---|
|
Age, Continuous
|
59.20 Years
STANDARD_DEVIATION 8.63 • n=5 Participants
|
|
Sex: Female, Male
Female
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8 Participants
n=5 Participants
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|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who received erythropoietin treatment and had the data available at least on Baseline and at the end of study evaluation period.
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.
Outcome measures
| Measure |
Participants With Cancer Related Anemia
n=19 Participants
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.
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|---|---|
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Percentage of Participants With Response to Erythropoietin Treatment
|
52.63 Percentage of participants
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SECONDARY outcome
Timeframe: BaselinePopulation: Participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation were analyzed.
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.
Outcome measures
| Measure |
Participants With Cancer Related Anemia
n=25 Participants
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.
|
|---|---|
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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
|
|
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
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SECONDARY outcome
Timeframe: BaselinePopulation: Participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation were analyzed.
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.
Outcome measures
| Measure |
Participants With Cancer Related Anemia
n=25 Participants
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.
|
|---|---|
|
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
|
|
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
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SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4 and Week 8Population: 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.
Hemoglobin is defined as a substance that carries oxygen and gives blood its red color.
Outcome measures
| Measure |
Participants With Cancer Related Anemia
n=19 Participants
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.
|
|---|---|
|
Serum Hemoglobin Level
Baseline (n=19)
|
9.96 Gram per deciliter (g per dl)
Standard Deviation 0.93
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|
Serum Hemoglobin Level
Week 1 (n=18)
|
9.94 Gram per deciliter (g per dl)
Standard Deviation 0.94
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|
Serum Hemoglobin Level
Week 2 (n=18)
|
10.00 Gram per deciliter (g per dl)
Standard Deviation 1.06
|
|
Serum Hemoglobin Level
Week 4 (n=18)
|
10.64 Gram per deciliter (g per dl)
Standard Deviation 1.59
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|
Serum Hemoglobin Level
Week 8 (n=7)
|
10.43 Gram per deciliter (g per dl)
Standard Deviation 1.49
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SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4 and Week 8Population: 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.
Hematocrit is the amount of red blood cells in the blood.
Outcome measures
| Measure |
Participants With Cancer Related Anemia
n=19 Participants
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.
|
|---|---|
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Serum Hematocrit Level
Baseline (n=19)
|
30.75 Percentage of red blood cells
Standard Deviation 3.34
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|
Serum Hematocrit Level
Week 1 (n=18)
|
30.59 Percentage of red blood cells
Standard Deviation 2.93
|
|
Serum Hematocrit Level
Week 2 (n=18)
|
30.76 Percentage of red blood cells
Standard Deviation 3.17
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|
Serum Hematocrit Level
Week 4 (n=18)
|
33.19 Percentage of red blood cells
Standard Deviation 5.41
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Serum Hematocrit Level
Week 8 (n=7)
|
33.01 Percentage of red blood cells
Standard Deviation 5.09
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SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4 and Week 8Population: 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.
Reticulocytes are immature red blood cells.
Outcome measures
| Measure |
Participants With Cancer Related Anemia
n=18 Participants
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.
|
|---|---|
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Reticulocyte Count
Baseline (n=18)
|
92.33 Nanogram per liter
Standard Deviation 58.27
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|
Reticulocyte Count
Week 1 (n=17)
|
64.81 Nanogram per liter
Standard Deviation 83.90
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|
Reticulocyte Count
Week 2 (n=16)
|
200.74 Nanogram per liter
Standard Deviation 110.37
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|
Reticulocyte Count
Week 4 (n=17)
|
120.68 Nanogram per liter
Standard Deviation 118.18
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|
Reticulocyte Count
Week 8 (n=7)
|
111.74 Nanogram per liter
Standard Deviation 70.37
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SECONDARY outcome
Timeframe: Baseline, Week 1 and Week 2Population: 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.
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.
Outcome measures
| Measure |
Participants With Cancer Related Anemia
n=19 Participants
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.
|
|---|---|
|
Serum Ferritin Level
Baseline (n=19)
|
807.28 Microgram per liter
Standard Deviation 746.84
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|
Serum Ferritin Level
Week 1 (n=18)
|
870.28 Microgram per liter
Standard Deviation 638.48
|
|
Serum Ferritin Level
Week 2 (n=18)
|
685.11 Microgram per liter
Standard Deviation 565.32
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SECONDARY outcome
Timeframe: Baseline, Week 1 and Week 2Population: 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.
Serum iron is a test that measures the amount of iron in the blood which is bound to transferrin.
Outcome measures
| Measure |
Participants With Cancer Related Anemia
n=18 Participants
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.
|
|---|---|
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Serum Iron Level
Week 1
|
89.22 Microgram per deciliter (Mcg per dl)
Standard Deviation 74.35
|
|
Serum Iron Level
Baseline
|
66.06 Microgram per deciliter (Mcg per dl)
Standard Deviation 65.04
|
|
Serum Iron Level
Week 2
|
53.06 Microgram per deciliter (Mcg per dl)
Standard Deviation 31.74
|
SECONDARY outcome
Timeframe: Baseline, Week 1 and Week 2Population: 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.
TIBC is a medical laboratory test that measures the blood's capacity to bind iron with transferrin.
Outcome measures
| Measure |
Participants With Cancer Related Anemia
n=19 Participants
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.
|
|---|---|
|
Transferring Iron Binding Capacity (TIBC)
Baseline (n=19)
|
275.26 Mcg per dl
Standard Deviation 54.62
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|
Transferring Iron Binding Capacity (TIBC)
Week 1 (n=18)
|
281.39 Mcg per dl
Standard Deviation 54.75
|
|
Transferring Iron Binding Capacity (TIBC)
Week 2 (n=18)
|
288.17 Mcg per dl
Standard Deviation 65.39
|
Adverse Events
Participants With Cancer Related Anemia
Serious adverse events
| Measure |
Participants With Cancer Related Anemia
n=25 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Vomitting
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Infections and infestations
Urinary Tract Infection
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.0%
2/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
Other adverse events
| Measure |
Participants With Cancer Related Anemia
n=25 participants at risk
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.
|
|---|---|
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Blood and lymphatic system disorders
Leukopenia
|
16.0%
4/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.0%
2/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
8.0%
2/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Nervous system disorders
Insomnia
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Nervous system disorders
Neuropathy peripheral
|
8.0%
2/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Metabolism and nutrition disorders
Fluid overload
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
24.0%
6/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
General disorders
Mucosal inflammation
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.0%
2/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
General disorders
Fatigue
|
8.0%
2/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Investigations
Blood creatinine increased
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Infections and infestations
Herpes zoster
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.0%
2/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Nervous system disorders
Tremor
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Cardiac disorders
Palpitation
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
|
Blood and lymphatic system disorders
Haemoglobinaemia
|
4.0%
1/25 • Baseline up to Week 8
Participants evaluated for safety included all the participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation.
|
Additional Information
Medical Affairs Director
Janssen Cilag Thailand
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place