Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients

Chugai Pharmaceutical160 enrolled

Overview

This is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 IU compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to anemic patients with lung cancer or gynecologic cancer undergoing chemotherapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

160

Conditions

Anemia

Interventions

epoetin betaDRUG

Subcutaneous administration of epoetin beta 36,000 IU once-weekly for 12 weeks

placeboDRUG

Subcutaneous administration of placebo once-weekly for 12 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Lung cancer or gynecologic cancer patients * Undergoing platinum-based chemotherapy repeated for ≧ 2 cycles after erythropoietin (EPO) or placebo administration * 8.0 g/dL ≦ hemoglobin concentration (Hb) ≦ 10.0 g/dL * 20 - 79 years old * Performance status: 0 - 2 * No iron deficiency anemia Exclusion Criteria: * Red blood cell transfusion within 4 weeks before treatment * Erythropoietin therapy within 8 weeks before treatment

Locations (6)

Chugoku/Shikoku Region

Chugoku/Shikoku, Japan

Chubu Region

Chūbu, Japan

Hokkaido/Tohoku Region

Hokkaido/Tohoku, Japan

Kanto/Koshinetsu Region

Kanto/Koshinetsu, Japan

Kinki/Hokuriku Region

Outcomes

Primary Outcomes

The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL

Time frame: 16 weeks

Secondary Outcomes

Change in Hb

Time frame: 16 weeks

Change in FACT- total Fatigue Subscale score (FSS)

Time frame: 16 weeks

Requirement for RBC transfusion

Time frame: 16 weeks

Data from ClinicalTrials.gov

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