Treatment for Patients With Gynecological Malignancies Who Suffer From Anemia Due to Chemotherapy

Amgen

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Gynecological Malignancies Genital Neoplasms, Female Anemia

Interventions

darbepoetin alfaDRUG

recombinant human erythropoietin (rHuEPO)DRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: - Subjects receiving multi-cycle chemotherapy for gynecological cancer - 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 - Known positive test for human immunodeficiency virus (HIV) infection

Outcomes

Primary Outcomes

Anemia correction

Secondary Outcomes

Patient preference

Activities of daily living

Data from ClinicalTrials.gov

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