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Treatment for Patients Suffering From Anemia Due to Chemotherapy

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ClinicalTrials.gov Identifier: NCT00120692
Recruitment Status : Completed
First Posted : July 19, 2005
Last Update Posted : December 24, 2007
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Anemia Drug: Darbepoetin Alfa Drug: Recombinant Human Erythropoietin Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2002
Estimated Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Anemia correction

Secondary Outcome Measures :
  1. Activities of daily living, patient preference

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120692


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00120692     History of Changes
Other Study ID Numbers: 20020152
First Posted: July 19, 2005    Key Record Dates
Last Update Posted: December 24, 2007
Last Verified: December 2007

Keywords provided by Amgen:
breast cancer
darbepoetin alfa
Amgen

Additional relevant MeSH terms:
Breast Neoplasms
Anemia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hematologic Diseases
Epoetin Alfa
Darbepoetin alfa
Hematinics