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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Montreal General Hospital
Montreal, Quebec, Canada
RECRUITINGpain relief; score on pain questionnaire
Time frame: at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
quality of life; score on 2 quality of life questionnaires
Time frame: at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
pain medication
Time frame: listed at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
side effects
Time frame: listed at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
cost of medical care
Time frame: evaluated at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
survival
Time frame: recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
new vertebral fractures
Time frame: recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
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