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

Completed

• Conditions: Neoplasms; Quality of Life; Cementoplasty

• Registration Number: NCT02082314
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-03-07
• Study First Posted: 2014-03-10
• Primary Completion: 2016-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain response	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

Name	Time	Method
Functional Interference	Baseline - 6 weeks post treatment	To investigate how functional interference of pain changes
Quality of Life	Baseline - 6 weeks post treatment	To investigate quality of life changes
Side-effects	Baseline-6 weeks post treatment	To investigate acute side effects of treatment

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada