Erythropoietin Spinal Cord Compression Randomized Trial
Nerve Compression Syndromes
Drug: Erythropoietin infusion
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Recombinant Human Erythropoietin (r-HuEPO) in the Prevention of Neurologic Sequelae From Malignant Spinal Cord Compression: a Multi-Center, Placebo-Controlled, Phase 2 Randomized Study|
- Overall survival
- Recovery of ambulation
- Deep vein thrombosis rate post-treatment
- The time to regain ambulation
- Duration of ambulatory function
- Health-related quality of life (HRQOL, prevalence of TVE at the time of randomization
|Study Start Date:||August 2005|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
For patients with malignant spinal cord compression (MSCC) who are paraparetic or paraplegic before initiating treatment, the current treatment options provide a meager to poor chance of neurologic recovery and the prognosis is guarded. Improving the chance of ambulation after treatment for MSCC may dramatically improve patients' quality of life, decrease days spent in hospital and improve survival. Steroids appear to prevent neurologic damage from MSCC and increasing doses appear to have an increasingly protective effect, however, higher doses are limited by an increasing incidence of serious toxicity.
Recombinant human erythropoetin has been shown to improve quality of life in patients with anemia of chronic disease and animal models suggest that r-HuEPO may have a neuroprotective effect. Human studies have demonstrated increased CSF concentrations of r-HuEPO after intravenous administration, including patients with MESCC. Furthermore, there is a suggestion that patients treated with intravenous r-HuEPO, steroids and RT may recover ambulatory function to a greater degree and faster than patients not treated with r-HuEPO.
Ultimately the effect of r-HuEPO in improving neurologic, functional and quality of life outcomes will need to be tested in a properly designed, large, randomized control trial. However, in order to successfully complete this study in a timely manner, a multicenter study will need to be performed. There are logistical issues that need to be addressed when setting up a r-HuEPO infusion program.
Therefore, a multicenter, randomized phase 2 study of intravenous r-HuEPO, steroids and RT will allow the investigators to address three issues: i) confirm that the logistical issues at each center can be addressed; ii) confirm in a larger cohort of patients whether the encouraging neurologic outcomes seen in the preliminary study can be replicated across different settings when compared with a randomized control group; iii) ensure the safety of EPO in this population including overall survival and incidence of subsequent TVEs with and without EPO.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220675
|London Regional Health Science Center|
|London, Ontario, Canada|
|Ottawa Regional Cancer Center|
|Ottawa, Ontario, Canada|
|Sunnybrook & Women's College Health Science Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Andrew Loblaw, MD MSc||Sunnybrook & Women's College Health Science Centre|