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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vertebroplasty | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| pain relief; score on pain questionnaire | at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan F Asenjo, MD | Contact | 514-934-1934 | 43261 | jfasenjog@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Juan F Asenjo, MD | Montreal General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal General Hospital | Recruiting | Montreal | Quebec | H3G 1A4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12160506 | Background | Saarto T, Janes R, Tenhunen M, Kouri M. Palliative radiotherapy in the treatment of skeletal metastases. Eur J Pain. 2002;6(5):323-30. doi: 10.1016/s1090-3801(02)00028-9. | |
| 11899906 | Background | Wu JS, Bezjak A, Chow E, Kirkbride P. Primary treatment endpoint following palliative radiotherapy for painful bone metastases: need for a consensus definition? Clin Oncol (R Coll Radiol). 2002 Feb;14(1):70-7. doi: 10.1053/clon.2001.0012. |
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| 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 |
| Background | McQuay HJ. The Cochrane Database of Systematic Reviews 3:---,2003. |
| Background | McLain R. Tumors of the Spine. In Herkowitz H et al. The Spine Philadelphia, WB Saunders Co 1171-1206, 1999. |
| 14527699 | Background | Niv D, Gofeld M, Devor M. Causes of pain in degenerative bone and joint disease: a lesson from vertebroplasty. Pain. 2003 Oct;105(3):387-392. doi: 10.1016/S0304-3959(03)00277-X. |
| 12865843 | Background | Molloy S, Mathis JM, Belkoff SM. The effect of vertebral body percentage fill on mechanical behavior during percutaneous vertebroplasty. Spine (Phila Pa 1976). 2003 Jul 15;28(14):1549-54. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054854 | Vertebroplasty |
| ID | Term |
|---|---|
| D060826 | Cementoplasty |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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