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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Sunnybrook Health Sciences Centre
Sponsor:
Information provided by (Responsible Party):
Dr. Elizabeth David, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT02082314
First received: February 24, 2014
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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
Neoplasms
Cementoplasty
Quality of Life

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 ] [ 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: February 2014
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02082314

Contacts
Contact: Elizabeth David, MD 416-480-6100 ext 2363

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Elizabeth David, MD    416-480-6100 ext 2363      
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Elizabeth David, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. Elizabeth David, PI, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02082314     History of Changes
Other Study ID Numbers: RFA
Study First Received: February 24, 2014
Last Updated: March 7, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
radiofrequency ablation
bone metastases

ClinicalTrials.gov processed this record on September 22, 2014