An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Budapest, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epoetin beta

Drug

Treatment will be given according to standard of care and the Summary of Product Characteristics during the study.

Other names: NeoRecormon

Primary outcomes

Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT)

Time frame: Baseline, Month 4

The change in Hb level from Baseline to the EOT visit at Month 4 was averaged among all participants and expressed in grams per liter (g/L).

Secondary outcomes

Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT

Time frame: Baseline, Month 4

ECOG performance status was determined at Baseline and at the EOT visit at Month 4. The assessment used a 3-point scale, including scores of 0 (fully active/able to carry on all pre-disease activities without restriction), 1 (restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work), or 2 (ambulatory for more than 50% of waking hours and capable of all self care but unable to carry out any work activities). The traditional 6-point scale was not valid because only participants with a performance status of 0, 1, or 2 were eligible for the study. The percentage of participants by change in ECOG performance status was reported. For example, the percentage of participants with ECOG performance status of 0 at Baseline and 2 at EOT is shown in the table as "Baseline 0, EOT 2". Transition to a lower performance status indicates improved/increased independence.
Percentage of Participants Who Required Blood Transfusions During the Study

Time frame: Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4

The percentage of participants who required blood transfusions was reported at each assessment visit and was based on the 1-month period preceding the respective visit.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Non-Interventional Study to Evaluate Treatment of Symptomatic Anemia in Patients With Malignancies Receiving Chemo- and NeoRecormon-Therapy

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Mar 12, 2013
Registry last updated: Aug 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed