Breast Cancer, Pain, Prostate Cancer, Vertebral Metastasis
Conditions
Keywords
breast cancer, prostate cancer, vertebral metastasis, vertebroplasty, vertebral metastasis from breast cancer, vertebral metastasis from prostate cancer
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.
Interventions
PROCEDUREVertebroplasty
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain relief; score on pain questionnaire | at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| cost of medical care | evaluated at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after |
Countries
Canada
Contacts
Primary ContactJuan F Asenjo, MD
Outcome results
None listed