An Observational Study to Predict the Response of Erythropoietin Treatment in Participants With Cancer Related Anemia Receiving Chemotherapy

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).

Study Overview

• Status: Terminated
• Conditions: Anemia - Cancer Related
• Intervention / Treatment: Drug: Erythropoietin: Observational study

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.

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand
  • Chiang Mai, Thailand
  • Khon Kaen, Thailand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participant with cancer related anemia receiving chemotherapy will be observed for response to erythropoietin treatment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Serum Hematocrit Level	Hematocrit is the amount of red blood cells in the blood.	Baseline, Week 1, Week 2, Week 4 and Week 8
Reticulocyte Count	Reticulocytes are immature red blood cells.	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.	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.	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.	Baseline, Week 1 and Week 2

Collaborators and Investigators

• Sponsor: Janssen-Cilag Ltd.,Thailand
• Collaborators: Mahidol University

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: November 26, 2012
• First Submitted That Met QC Criteria: November 26, 2012
• First Posted (Estimate): November 29, 2012

Study Record Updates

• Last Update Posted (Estimate): April 29, 2014
• Last Update Submitted That Met QC Criteria: March 28, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Anemia - cancer related; Eprex (Erythropoietin alfa)
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: CR016558; EPOCAN4028