This study will evaluate the efficacy and tolerability of subcutaneous (SC) or intramuscular (IM) recombinant human erythropoietin beta (r-HuEPO) in participants with anemia and histologically or cytologically confirmed cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
All participants will receive r-HuEPO for 4 weeks, at a dose of 10000 international units per day (IU/day) according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
Unnamed facility
Bari, Italy
Unnamed facility
Benevento, Italy
Unnamed facility
Cagliari, Italy
Unnamed facility
Campobasso, Italy
Unnamed facility
Percentage of Participants With Response to Treatment
Response to treatment was defined as an increase of greater than (\>) 1 gram per deciliter (g/dL) in hemoglobin level (irrespective of the need of transfusion) from Baseline value at Week 4.
Time frame: Week 4
Time to Response
Time to response was defined as the time between the start of treatment and the increase in hemoglobin level \>1 g/dL compared to baseline hemoglobin level. Time to response was estimated using Kaplan Meier method.
Time frame: Baseline up to Week 4
Percentage of Participants With Response to Treatment After 2 Weeks of Study Treatment
Response to treatment after 2 weeks of treatment was defined as presence of any of the following criteria: reticulocytes \>40000 per microliter or \>25% increase in soluble transferrin receptor or \>0.5 g/dL increase in hemoglobin level.
Time frame: Week 2
Percentage of Participants With No Response to Treatment After 4 Weeks of Study Treatment
"No Response" to treatment after 4 weeks was defined as meeting any of the following criteria: \<1 g/dL increase in hemoglobin level or hemoglobin level \<8.5 g/dL or need of transfusion. If a participant had an increase in hemoglobin level of \>1 g/dL but required transfusion then the participant is considered as Non- Responder.
Time frame: Week 4
Percentage of Participants Who Required Transfusion
Time frame: Baseline, Week 2, Week 4
Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Score at Week 4
FACT-An comprises of 4 subscales of 27-item (FACT-General scale \[FACT-G\]): physical well-being, social/family well-being, emotion well-being, functional well-being, and an additional concerns anemia subscale. All questions are rated on a scale from 0 to 4, where higher scores indicate more impact on quality of life. The physical well-being subscale consists of 7 questions with score range from 0-28; social/family well-being subscale consists of 7 questions with score range from 0-28; emotion well-being subscale consists of 6 questions with score range from 0-24; functional well-being subscale consists of 7 questions with score range from 0-28; anemia subscale consist of 20 questions with score range from 0-80. Total FACT-An score ranges from 0-188.
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Napoli, Italy
Unnamed facility
Palermo, Italy
Unnamed facility
Palermo, Italy
Time frame: Baseline, Week 4