NCT01736215

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: Janssen-Cilag Ltd.,Thailand · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Anemia - Cancer Related

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-11-29
• Last updated: 2014-04-29
• Results posted: 2013-05-30

Locations

3 sites across 1 country: Thailand