Breast Cancer Clinical Trial
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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