An observational study in Anemia and Neoplasms, sponsored by Janssen-Cilag B.V.. Completed at 20 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-07.
Sponsored by Janssen-Cilag B.V. · Observational
The purpose of this study is to evaluate the cost-effectiveness of epoetin alfa compared with darbepoetin alfa in the treatment of anemia in adults receiving chemotherapy for cancer. Epoetin alfa and darbepoetin alfa are genetically engineered proteins that stimulate red blood cell production.
Anemia has been identified as a common complication and a widespread problem in the cancer population. Anemia is a condition in which a patient has below normal levels of hemoglobin, the substance in red blood cells that carries oxygen to all parts of the body. People with severe anemia may experience fatigue and shortness of breath with activity. Therefore, this condition can have a negative influence on a person's quality of life. Epoetin alfa and darbepoetin alfa, used to treat anemia in cancer patients, are genetically engineered proteins that stimulate red blood cell production. This study investigates treatment of anemia using either epoetin alfa or darbepoetin alfa during chemotherapy in adult patients with cancer. The study is intended to collect information on normal medical practice and routine anemia management performed at the participating centers. This is an observational, non-randomized, prospective, comparative, parallel-group survey performed in The Netherlands. Patients with various severities of disease may enter the survey as soon as either their epoetin alfa or their darbepoetin alfa treatment starts and will be followed until the end of their epoetin alfa/darbepoetin alfa treatment. Patient data are collected, on average, once monthly (depending on the treatment being received) and this continues until 4 weeks after the end of treatment with epoetin alfa or darbepoetin alfa. An assessment of cost-effectiveness will be made for both treatments. The assessment of cost-effectiveness will be based on the following: cancer type and status, chemotherapy and other anti-cancer treatment, hemoglobin levels, use of either epoetin alfa or darbepoetin alfa, use of blood transfusions, and serum iron levels and iron supplementation. Safety evaluations include the incidence of serious and non-serious adverse events. Because the study involves only collection of information, no treatment will be required by the Sponsor and no medication will be supplied by the Sponsor. Epoetin alpha and darbepoetin alpha are administered according to routine clinical practice.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 492 is above the median of 200 across 326 observational studies indexed under Anemia.
Browse Anemia studies →Janssen-Cilag B.V. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cancer patients receiving epoetin- or darbepoetin alfa as anemia treatment during chemotherapy, as part of the common practice of participating physicians. Patients may enter the study as soon as either their epoetin alfa or their darbepoetin alfa treatment starts.
Exclusion Criteria:
Epoetin alfa 40 000 IU once weekly variable treatment length.
Drug: Epoetin alfa
Darbepoetin alfa Either 150 ug once weekly or 500 ug once every 3 wks variable treatment length.
Drug: Darbepoetin alfa
Either 150 ug once weekly or 500 ug once every 3 wks, variable treatment length.
40,000 IU once weekly, variable treatment length.
Cost-effectiveness based on: cancer type and status, chemotherapy and other anti-cancer treatment, hemoglobin levels, use of either epoetin alfa or darbepoetin alfa, use of blood transfusions, serum iron levels and iron supplementation.
Time frame: 4 weeks, 8 weeks and end of treatment
Safety evaluations including the incidence of serious and non-serious adverse events.
Time frame: from start of (Darb)epoetin treatment to end of study.
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Janssen-Cilag B.V.