Spots Global Cancer Trial Database for Potential Vertebroplasty Use in the Treatment of Vertebral Metastasis From Breast and Prostate Cancer

Study Description

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.

Keywords

Eligibility

Minimum Age: 35 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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