Potential Vertebroplasty Use in the Treatment of Vertebral Metastasis From Breast and Prostate Cancer

Phase 3

• Conditions: Breast Cancer; Prostate Cancer; Vertebral Metastasis; Pain

• Registration Number: NCT00294151
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

The study aims to evaluate if adding vertebroplasty to radiotherapy, in the treatment of spine metastasis from breast and prostate cancer, is preferable to radiotherapy alone. The investigators hypothesize that, by combining vertebral augmentation with cement and radiotherapy, they could achieve an enhancement in pain relief and level of activities, as well as a decrease in the side effects of multiple medications used for pain control.

Detailed Description

Included patients presenting with spinal metastasis secondary to breast or prostate cancer are randomized to two groups, intervention and control. Both groups receive standard radiotherapy, which is currently the gold standard of care for such patients. The intervention group will also receive a vertebroplasty \[single or multiple level(s)\], while the control group will receive a simulated vertebroplasty, where local anesthesia and gentle hand manipulation will be used but the vertebra will not be accessed. The primary outcome is pain relief, though other factors such as quality of life and pain medications will also be evaluated.

There will be an interim analysis after half of the patients have been treated with a follow-up of 3 months. In the analysis, comparisons will be made between the two groups and each patient's individual progress will also be analyzed.

Study Timeline

• Study Start: 2005-09
• Status Verified: 2006-01
• Study First Submitted: 2006-02-17
• Study First Submitted QC: 2006-02-17
• Study First Posted: 2006-02-20
• Last Update Submitted: 2007-07-12
• Last Update Posted: 2007-07-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Between 35 and 75 years old
• Biopsy-proven breast cancer (BC) or prostate cancer (PC)
• Radiographic evidence of spine metastases from the BC or PC in the lumbar and/or mid-low thoracic spine
• Microfractures or compression fractures up to 40% of the original height of the vertebral body in an MRI [magnetic resonance imaging] (reported by an independent radiologist)
• Incidental back pain (Verbal Analog Scale > 5/10) felt to be related to those metastases

Exclusion Criteria

• Spinal cord compression
• Massive rupture of the posterior wall of the vertebral body (according to blinded radiological report)
• Coagulopathy (International Normalized Ratio [INR] > 1.5, platelets < 80,000)
• Inability to communicate in English, French or Spanish
• Previous radiotherapy to the spine in the area presently affected
• Mental cognitive impairment
• Vertebral metastasis without fracture in the MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pain relief; score on pain questionnaire	at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after

Secondary Outcome Measures

Name	Time	Method
quality of life; score on 2 quality of life questionnaires	at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
pain medication	listed at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
side effects	listed at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
cost of medical care	evaluated at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
survival	recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
new vertebral fractures	recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after

Trial Locations

Locations (1)

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada