Clinical trial NCT01809314: An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy
Official title: Non-Interventional Study to Evaluate Treatment of Symptomatic Anemia in Patients With Malignancies Receiving Chemo- and NeoRecormon-Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-03-12
Enrollment: 1167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with symptomatic anemia due to malignancies will be included.

Brief summary: This observational study will evaluate the efficacy and safety of epoetin beta (NeoRecormon) in participants with symptomatic anemia and cancer receiving chemotherapy. Participants receiving NeoRecormon once weekly in accordance with the Summary of Product Characteristics will be followed for 4 months.


Eligibility criteria: Inclusion Criteria:

* Adults greater than or equal to (≥) 18 years of age
* Participants with solid tumors or lymphoproliferative disease
* Participants receiving chemotherapy
* Participants for whom erythropoietin is indicated for pre-study Hb level and observed anemic symptoms: Hb less than (\<) 11 g/dL or 6.83 millimoles per liter (mmol/L)
* ECOG performance status of 0, 1, or 2

Exclusion Criteria:

* Resistant hypertension
* Acute chronic bleeding within 3 months prior to study
* Iron deficiency that is unmanageable prior to study
* Hypersensitivity to the active substance or any of the excipients of the product
* Pregnant or breastfeeding women
* Epoetin treatment within 6 months prior to study

Primary outcomes:
measure: Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT)
timeFrame: Baseline, Month 4
Secondary outcomes:
measure: Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT
timeFrame: Baseline, Month 4
measure: Percentage of Participants Who Required Blood Transfusions During the Study
timeFrame: Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4
Other outcomes:
Locations:
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Debrecen
country: Hungary
city: Debrecen
country: Hungary
city: Deszk
country: Hungary
city: Dunaujvaros
country: Hungary
city: Eger
country: Hungary
city: Farkasgyepu
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Kaposvar
country: Hungary
city: Kecskemet
country: Hungary
city: Miskolc
country: Hungary
city: Miskolc
country: Hungary
city: Mosdos
country: Hungary
city: Nyíregyháza
country: Hungary
city: Pecs
country: Hungary
city: Pecs
country: Hungary
city: Pecs
country: Hungary
city: Salgótarján
country: Hungary
city: Szeged
country: Hungary
city: Szekesfehervar
country: Hungary
city: Szekesfehervar
country: Hungary
city: Szekszard
country: Hungary
city: Szolnok
country: Hungary
city: Szolnok
country: Hungary
city: Szombathely
country: Hungary
city: Székesfehérvár
country: Hungary
city: Tatabánya
country: Hungary
city: Torokbalint
country: Hungary
city: Veszprem
country: Hungary
city: Zalaegerszeg
country: Hungary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: