Potential Vertebroplasty Use in the Treatment of Vertebral Metastasis From Breast and Prostate Cancer

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00294151
• Other study ID #: GEN#05-015
• Status: Recruiting
• Phase: Phase 3
• First received: February 17, 2006
• Last updated: July 12, 2007
• Start date: September 2005

Study information

• Verified date: January 2006
• Source: McGill University Health Center
• Contact: Juan F Asenjo, MD
• Phone: 514-934-1934
• Email: jfasenjog[@]yahoo.com
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Neoplasm Metastasis
• Pain
• Prostate Cancer
• Prostatic Neoplasms
• Vertebral Metastasis

Intervention

Procedure:
• Vertebroplasty

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

References & Publications (6)

Barden J, Edwards JE, McQuay HJ, Moore RA. Single dose oral celecoxib for postoperative pain. Cochrane Database Syst Rev. 2003;(2):CD004233. Review. Update in: Cochrane Database Syst Rev. 2008;(4):CD004233. — View Citation

McLain R. Tumors of the Spine. In Herkowitz H et al. The Spine Philadelphia, WB Saunders Co 1171-1206, 1999.

Molloy 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. — View Citation

Niv D, Gofeld M, Devor M. Causes of pain in degenerative bone and joint disease: a lesson from vertebroplasty. Pain. 2003 Oct;105(3):387-92. Review. — View Citation

Saarto T, Janes R, Tenhunen M, Kouri M. Palliative radiotherapy in the treatment of skeletal metastases. Eur J Pain. 2002;6(5):323-30. Review. — View Citation

Wu 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain relief; score on pain questionnaire		at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
Secondary	quality of life; score on 2 quality of life questionnaires		at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
Secondary	pain medication		listed at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
Secondary	side effects		listed at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
Secondary	cost of medical care		evaluated at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
Secondary	survival		recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
Secondary	new vertebral fractures		recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after