Clinical trial · Interventional
Potential Vertebroplasty Use in the Treatment of Vertebral Metastasis From Breast and Prostate Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Pain | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Vertebral Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vertebroplasty | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- pain relief; score on pain questionnaire
- timeFrame
- at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
Secondary outcomes (6)
- measure
- quality of life; score on 2 quality of life questionnaires
- timeFrame
- at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
- measure
- pain medication
- timeFrame
- listed at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
- measure
- side effects
- timeFrame
- listed at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Between 35 and 75 years old * Biopsy-proven breast cancer (BC) or prostate cancer (PC) * Radiographic evidence of spine metastases from the BC or PC in the lumbar and/or mid-low thoracic spine * Microfractures or compression fractures up to 40% of the original height of the vertebral body in an MRI \[magnetic resonance imaging\] (reported by an independent radiologist) * Incidental back pain (Verbal Analog Scale \> 5/10) felt to be related to those metastases Exclusion Criteria: * Spinal cord compression * Massive rupture of the posterior wall of the vertebral body (according to blinded radiological report) * Coagulopathy (International Normalized Ratio \[INR\] \> 1.5, platelets \< 80,000) * Inability to communicate in English, French or Spanish * Previous radiotherapy to the spine in the area presently affected * Mental cognitive impairment * Vertebral metastasis without fracture in the MRI
References
Publications (6)
- BACKGROUNDSaarto 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. PMID 12160506
- BACKGROUNDWu 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. PMID 11899906
- BACKGROUNDMcQuay HJ. The Cochrane Database of Systematic Reviews 3:---,2003.
- BACKGROUNDMcLain R. Tumors of the Spine. In Herkowitz H et al. The Spine Philadelphia, WB Saunders Co 1171-1206, 1999.
- BACKGROUNDNiv 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. PMID 14527699
- BACKGROUNDMolloy 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. PMID 12865843