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

This study has been completed.
Information provided by (Responsible Party):
Dr. Elizabeth David, Sunnybrook Health Sciences Centre Identifier:
First received: February 24, 2014
Last updated: October 12, 2016
Last verified: October 2016

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 Intervention
Quality of Life
Procedure: RFA Vertebroplasty

Study Type: Observational
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

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Pain response [ Time Frame: 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 [ Time Frame: Baseline - 6 weeks post treatment ]
    To investigate how functional interference of pain changes

  • Quality of Life [ Time Frame: Baseline - 6 weeks post treatment ]
    To investigate quality of life changes

  • Side-effects [ Time Frame: Baseline-6 weeks post treatment ]
    To investigate acute side effects of treatment

Enrollment: 10
Study Start Date: February 2014
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will be derived from patients with advanced cancers with spinal/pelvic metastases who have been referred to interventional radiology and have consented to receiving RFA and/or cementoplasty for their disease. Such patients will be followed with a daily diary for 10 days after treatment. The Brief Pain Inventory will be used to assess pain and functional interference on these days.

Inclusion Criteria:

  1. Histologically or cytologically proven malignancy.
  2. Patients aged 18 and above.
  3. Advanced cancer with bone metastasis(es) to the spine and/or pelvis
  4. Symptomatic with axial pain from spinal lesions and at risk for pathological fracture, or, pathological fracture without spinal cord compromise
  5. Karnofsky Performance Status (KPS) greater than or equal to 40 at the time of baseline evaluation.
  6. Is planned to receive RFA and/or cementoplasty with treatment to all sites being followed for study.
  7. Is able to provide worst pain score at bony metastatic site(s).
  8. Patient is able and willing to fill out daily diary.
  9. Patients must be able to provide informed consent prior to being enrolled to the study.

Exclusion Criteria:

  1. Progressive neurological compromise
  2. Pathological fracture of vertebrae with significant cortical involvement or spinal canal compromise
  3. Central nervous system metastases
  4. Inability to record pain score, complete diary and communicate this to study personnel.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02082314

Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Principal Investigator: Elizabeth David, MD Sunnybrook Health Sciences Centre
  More Information

Responsible Party: Dr. Elizabeth David, PI, Sunnybrook Health Sciences Centre Identifier: NCT02082314     History of Changes
Other Study ID Numbers: RFA
Study First Received: February 24, 2014
Last Updated: October 12, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Sunnybrook Health Sciences Centre:
radiofrequency ablation
bone metastases processed this record on April 25, 2017