Status:
TERMINATED
A Phase III Clinical Trial of PROCRIT (Epoetin Alfa) Versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer
Lead Sponsor:
Ortho Biotech Products, L.P.
Conditions:
Anemia
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 c...
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 in...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00246597
Start Date
December 1 2002
End Date
June 1 2004
Last Update
May 19 2011
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