Treatment for Patients Suffering From Anemia Due to Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2003-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Anemia

Keywords

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breast cancer darbepoetin alfa Amgen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Darbepoetin Alfa

Intervention Type DRUG

Recombinant Human Erythropoietin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Female subjects receiving multi-cycle chemotherapy - Anemia due to chemotherapy (hgb less than or equal to 11.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Amgen Inc.

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

References

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Senecal FM, Yee L, Gabrail N, Charu V, Tomita D, Rossi G, Schwartzberg L. Treatment of chemotherapy-induced anemia in breast cancer: results of a randomized controlled trial of darbepoetin alfa 200 microg every 2 weeks versus epoetin alfa 40,000 U weekly. Clin Breast Cancer. 2005 Dec;6(5):446-54. doi: 10.3816/cbc.2005.n.050.

Reference Type RESULT

PMID: 16381629 (View on PubMed)

Other Identifiers

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20020152

Identifier Type: -

Identifier Source: org_study_id