Trial Information

Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2

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, used to
treat anemia in cancer patients, is a genetically engineered protein that stimulates red
blood cell production. This study investigates treatment of anemia using epoetin 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 their epoetin alfa treatment starts and will be followed until the end
of their epoetin alfa treatment. Patient data are collected in Case Report Forms (CRFs)
until 4 weeks after the end of treatment with epoetin alfa. At the end of treatment
completed CRFs will be collected. The assessment of effectiveness/response will be based on
the following: cancer type and status, chemotherapy and other anti-cancer treatment,
hemoglobin levels, 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 is observational, dosage, administration and duration of treatment
is at discretion of treating physician.