Prospective Study Determining the Pain Response, Functional Interference and Quality of Life in Patients Undergoing Radiofrequency Ablation Assisted Vertebroplasty/ Cementoplasty (RFA)
Bone metastases are a cause of significant morbidity in cancer patients. In patients who die from breast, prostate, and lung cancer, autopsy studies have shown that up to 85% have evidence of bone metastases at the time of death (1). These metastases frequently give rise to complications that reduce patients' quality of life. These include: pain, fractures, and decreased mobility, ultimately reducing performance status.
Radiofrequency ablation therapy with cementoplasty/vertebroplasty for painful bone metastases has been shown to be feasible, efficacious, and safe. However, patient reported outcomes have yet to be determined.
Quality of Life
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective Study Determining the Pain Response, Functional Interference and Quality of Life in Patients Undergoing Radiofrequency Ablation Assisted Vertebroplasty/ Cementoplasty|
- Pain response [ Time Frame: Baseline to 6 weeks post treatment ] [ Designated as safety issue: No ]To determine the complete and partial pain response rates in patients who undergo radiofrequency ablation (RFA) and/or cementoplasty/vertebroplasty for spinal/pelvic metastases.
- Functional Interference [ Time Frame: Baseline - 6 weeks post treatment ] [ Designated as safety issue: No ]To investigate how functional interference of pain changes
- Quality of Life [ Time Frame: Baseline - 6 weeks post treatment ] [ Designated as safety issue: No ]To investigate quality of life changes
- Side-effects [ Time Frame: Baseline-6 weeks post treatment ] [ Designated as safety issue: No ]To investigate acute side effects of treatment
|Study Start Date:||February 2014|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02082314
|Contact: Elizabeth David, MD||416-480-6100 ext 2363|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Elizabeth David, MD 416-480-6100 ext 2363|
|Principal Investigator:||Elizabeth David, MD||Sunnybrook Health Sciences Centre|