Clinical trial NCT01736215: An Observational Study to Predict the Response of Erythropoietin Treatment in Participants With Cancer Related Anemia Receiving Chemotherapy
Official title: Prediction of Response to Erythropoietin Treatment in Cancer Related Anemia Patients Receiving Chemotherapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anemia - Cancer Related
Keywords: Anemia - cancer related
Eprex (Erythropoietin alfa)
Lead sponsor: Janssen-Cilag Ltd.,Thailand
Sponsor class: INDUSTRY
Collaborators: name: Mahidol University
First posted: 2012-11-29
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participant with cancer related anemia receiving chemotherapy will be observed for response to erythropoietin treatment.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Response to Erythropoietin Treatment
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of Participants With Serum Erythropoietin (EPO) Level (EPO Less Than or Equal to 45.2 or EPO Greater Than 45.3)
timeFrame: Baseline
measure: Number of Participants With C-Reactive Protein (CRP) Level Less Than or Equal to 10.3 or Greater Than 10.4
timeFrame: Baseline
measure: Serum Hemoglobin Level
timeFrame: Baseline, Week 1, Week 2, Week 4 and Week 8
measure: Serum Hematocrit Level
timeFrame: Baseline, Week 1, Week 2, Week 4 and Week 8
measure: Reticulocyte Count
timeFrame: Baseline, Week 1, Week 2, Week 4 and Week 8
measure: Serum Ferritin Level
timeFrame: Baseline, Week 1 and Week 2
measure: Serum Iron Level
timeFrame: Baseline, Week 1 and Week 2
measure: Transferring Iron Binding Capacity (TIBC)
timeFrame: Baseline, Week 1 and Week 2
Other outcomes:
Locations:
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Khon Kaen
country: Thailand
Study officials:
affiliation: Janssen-Cilag Ltd.,Thailand
name: Janssen-Cilag Ltd.,Thailand Clinical Trial
role: STUDY_DIRECTOR
References: