A Phase III Clinical Trial of PROCRIT (Epoetin Alfa) Versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer

NCT ID: NCT00246597

Last Updated: 2011-05-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2004-06-30

Brief Summary

The purpose of this study is to determine whether it is possible to measure temporary difficulty with thinking and/or short-term memory in women who are receiving chemotherapy for early stage breast cancer and to determine whether or not treatment with PROCRIT® will help decrease any problems with thinking or short-term memory that chemotherapy may cause.

Detailed Description

Studies of the effect of erythropoietin on rat and mouse brain suggests a neuroprotective and cognitive-enhancing effect of this hormone. The objective of this study was to quantify and compare the incidence of chemotherapy-related impairment of cognitive and executive function in breast cancer patients randomized to receive PROCRIT versus placebo while receiving adjuvant anthracycline-based chemotherapy with or without a Taxane and to evaluate the effect of PROCRIT® on the incidence of asthenia (severe fatigue), quality of life (QoL), and mood. Patients received study medication injections (40,000 units) under their skin once every week for 12 to 24 weeks of chemotherapy. Doses were adjusted depending on the patients' hemoglobin level up to a maximum of 60,000 units.

Conditions

Anemia; Breast Neoplasms; Hemoglobins; Quality of Life; Chemotherapy, Adjuvant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

epoetin alfa

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologic diagnosis of Stage I, II or III cancer (chemotherapy naïve for breast cancer) with anthracycline-based adjuvant chemotherapy with or without a taxane
• Hemoglobin >=9 and <=14 g/dL unrelated to transfusion
• Able to read, understand and complete QoL & Cognition tools
• Patients with reproductive potential must have a negative serum pregnancy test within 7 days of study enrollment and use an adequate contraceptive method

Exclusion Criteria

• Patients who will receive more than a total of 24 weeks of chemotherapy
• psychiatric or neurologic condition that would prevent informed consent and completion of questionnaires or that is poorly controlled with the current treatment regimen
• severe hemiparesis or other condition, distal neuropathy, action tremor or other motor dysfunction, visual deficiencies preventing/decrease bimanual keyboard operation
• severe bradyphrenia (slow thinking) or bradykinesia (slow movement)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ortho Biotech Products, L.P.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Ortho Biotech Products, L.P. Clinical Trial

Role: STUDY_DIRECTOR

Ortho Biotech Products, L.P.

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=921&filename=CR002305_CSR.pdf

A Phase III Clinical Trial of PROCRIT� (Epoetin alfa) versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer

Other Identifiers

CR002305

Identifier Type: -

Identifier Source: org_study_id