Prospective Study Determining the Pain Response, Functional Interference and Quality of Life in Patients Undergoing Radiofrequency Ablation Assisted Vertebroplasty/ Cementoplasty

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Study Determining the Pain Response, Functional Interference and Quality of Life in Patients Undergoing Radiofrequency Ablation Assisted Vertebroplasty/ Cementoplasty

Conditions
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Neoplasms, Cementoplasty, Quality of Life

Intervention / Treatment
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* Procedure: RFA Vertebroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically proven malignancy. Patients aged 18 and above. Advanced cancer with bone metastasis(es) to the spine and/or pelvis Symptomatic with axial pain from spinal lesions and at risk for pathological fracture, or, pathological fracture without spinal cord compromise Karnofsky Performance Status (KPS) greater than or equal to 40 at the time of baseline evaluation. Is planned to receive RFA and/or cementoplasty with treatment to all sites being followed for study. Is able to provide worst pain score at bony metastatic site(s). Patient is able and willing to fill out daily diary. Patients must be able to provide informed consent prior to being enrolled to the study. Exclusion Criteria: Progressive neurological compromise Pathological fracture of vertebrae with significant cortical involvement or spinal canal compromise Central nervous system metastases Inability to record pain score, complete diary and communicate this to study personnel.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: RFA Vertebroplasty|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain response | To determine the complete and partial pain response rates in patients who undergo radiofrequency ablation (RFA) and/or cementoplasty/vertebroplasty for spinal/pelvic metastases. | Baseline to 6 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Interference | To investigate how functional interference of pain changes | Baseline - 6 weeks post treatment | 
| Quality of Life | To investigate quality of life changes | Baseline - 6 weeks post treatment | 
| Side-effects | To investigate acute side effects of treatment | Baseline-6 weeks post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiofrequency ablation, bone metastases