An Observational Study to Predict the Response of Erythropoietin Treatment in Participants With Cancer Related Anemia Receiving Chemotherapy
Information source: Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anemia - Cancer Related
Intervention: Erythropoietin: Observational study (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Janssen-Cilag Ltd.,Thailand Official(s) and/or principal investigator(s): Janssen-Cilag Ltd.,Thailand Clinical Trial, Study Director, Affiliation: Janssen-Cilag Ltd.,Thailand
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).
Clinical Details
Official title: Prediction of Response to Erythropoietin Treatment in Cancer Related Anemia Patients Receiving Chemotherapy
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Percentage of Participants With Response to Erythropoietin Treatment
Secondary outcome: Number of Participants With Serum Erythropoietin (EPO) Level (EPO Less Than or Equal to 45.2 or EPO Greater Than 45.3)Number of Participants With C-Reactive Protein (CRP) Level Less Than or Equal to 10.3 or Greater Than 10.4 Serum Hemoglobin Level Serum Hematocrit Level Reticulocyte Count Serum Ferritin Level Serum Iron Level Transferring Iron Binding Capacity (TIBC)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Bangkok, Thailand
Chiang Mai, Thailand
Khon Kaen, Thailand
Additional Information
Starting date: November 2010
Last updated: March 28, 2014
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