Trials / Terminated
TerminatedNCT00246597
A Phase III Clinical Trial of PROCRIT (Epoetin Alfa) Versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Ortho Biotech Products, L.P. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | epoetin alfa |
Timeline
- Start date
- 2002-12-01
- Completion
- 2004-06-01
- First posted
- 2005-10-31
- Last updated
- 2011-05-19
Source: ClinicalTrials.gov record NCT00246597. Inclusion in this directory is not an endorsement.