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

October 12, 2016 updated by: Dr. Elizabeth David, Sunnybrook Health Sciences Centre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 6 weeks post treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Elizabeth David, MD, Sunnybrook Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 10, 2014

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RFA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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