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

NCT02082314 | Completed

• 1 other identifier: RFA
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Cementoplasty; Quality of Life

Keywords

radiofrequency ablation; bone metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Functional Interference

  Baseline - 6 weeks post treatment

• Quality of Life

  Baseline - 6 weeks post treatment

• Side-effects

  Baseline-6 weeks post treatment

Interventions

RFA Vertebroplasty PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Elizabeth David, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: March 10, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2016
• Last Updated: October 14, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)