Potential Vertebroplasty Use in the Treatment of Vertebral Metastasis From Breast and Prostate Cancer
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Challenging the Paradigm in Pain Relief for Advanced Breast and Prostate Cancer Patients With Vertebral Metastasis: Vertebral Augmentation With Cement Plus Radiotherapy Versus Radiotherapy. A Randomized, Prospective, Double Blind Pilot Study|
- pain 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 ]
|Study Start Date:||September 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00294151
|Contact: Juan F Asenjo, MD||514-934-1934 ext email@example.com|
|Montreal General Hospital||Recruiting|
|Montreal, Quebec, Canada, H3G 1A4|
|Principal Investigator: Juan F Asenjo, MD|
|Principal Investigator:||Juan F Asenjo, MD||Montreal General Hospital|