Treatment for Patients Suffering From Anemia Due to Chemotherapy

An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Female Breast Cancer Patients Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00120692

Enrollment

Unknown

Registered

2005-07-19

Start date

2002-10-31

Completion date

2003-12-31

Last updated

2007-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Breast Cancer

Keywords

breast cancer, darbepoetin alfa, Amgen

Brief summary

The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in female breast cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.

Interventions

DRUGDarbepoetin Alfa

DRUGRecombinant Human Erythropoietin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- Female subjects receiving multi-cycle chemotherapy - Anemia due to chemotherapy (hgb less than or equal to 11.0 g/dL) - Expected to receive greater than or equal to 8 additional weeks of chemotherapy as part of their planned treatment - Karnofsky Performance Scale (KPS) greater than or equal to 50% - Adequate renal function - Adequate liver function

Exclusion criteria

- Iron deficiency - Unstable cardiac disease - Known positive test for human immunodeficiency virus (HIV) infection

Design outcomes

Primary

Measure	Time frame
Anemia correction	—

Secondary

Measure	Time frame
Activities of daily living, patient preference	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026