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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-02-29

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Anemia - Cancer Related

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with cancer related anemia

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

Erythropoietin: Observational study

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No