Potential Vertebroplasty Use in the Treatment of Vertebral Metastasis From Breast and Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00294151|
Recruitment Status : Unknown
Verified January 2006 by McGill University Health Center.
Recruitment status was: Recruiting
First Posted : February 20, 2006
Last Update Posted : July 13, 2007
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Prostate Cancer Vertebral Metastasis Pain||Procedure: Vertebroplasty||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||September 2005|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294151
|Contact: Juan F Asenjo, MD||514-934-1934 ext firstname.lastname@example.org|
|Montreal General Hospital||Recruiting|
|Montreal, Quebec, Canada, H3G 1A4|
|Principal Investigator: Juan F Asenjo, MD|
|Principal Investigator:||Juan F Asenjo, MD||Montreal General Hospital|