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

McGill University

Status and phase

Unknown

Phase 3

Conditions

Breast Cancer

Vertebral Metastasis

Pain

Prostate Cancer

Treatments

Procedure: Vertebroplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT00294151

GEN#05-015

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

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