RFA: Prospective Study Determining the Pain Response, Functional Interference and Quality of Life in Patients Undergoing Radiofrequency Ablation Assisted Vertebroplasty/ Cementoplasty
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Pain response [Baseline to 6 weeks post treatment]
To determine the complete and partial pain response rates in patients who undergo radiofrequency ablation (RFA) and/or cementoplasty/vertebroplasty for spinal/pelvic metastases.
Secondary Outcome Measures
- Functional Interference [Baseline - 6 weeks post treatment]
To investigate how functional interference of pain changes
- Quality of Life [Baseline - 6 weeks post treatment]
To investigate quality of life changes
- Side-effects [Baseline-6 weeks post treatment]
To investigate acute side effects of treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically or cytologically proven malignancy.
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Patients aged 18 and above.
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Advanced cancer with bone metastasis(es) to the spine and/or pelvis
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Symptomatic with axial pain from spinal lesions and at risk for pathological fracture, or, pathological fracture without spinal cord compromise
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Karnofsky Performance Status (KPS) greater than or equal to 40 at the time of baseline evaluation.
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Is planned to receive RFA and/or cementoplasty with treatment to all sites being followed for study.
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Is able to provide worst pain score at bony metastatic site(s).
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Patient is able and willing to fill out daily diary.
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Patients must be able to provide informed consent prior to being enrolled to the study.
Exclusion Criteria:
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Progressive neurological compromise
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Pathological fracture of vertebrae with significant cortical involvement or spinal canal compromise
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Central nervous system metastases
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Inability to record pain score, complete diary and communicate this to study personnel.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
Sponsors and Collaborators
- Sunnybrook Health Sciences Centre
Investigators
- Principal Investigator: Elizabeth David, MD, Sunnybrook Health Sciences Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RFA