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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2006 by McGill University Health Center.
Recruitment status was:  Recruiting
Information provided by:
McGill University Health Center Identifier:
First received: February 17, 2006
Last updated: July 12, 2007
Last verified: January 2006
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.

Condition Intervention Phase
Breast Cancer
Prostate Cancer
Vertebral Metastasis
Procedure: Vertebroplasty
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • pain relief; score on pain questionnaire [ Time Frame: at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: September 2005
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.


Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00294151

Contact: Juan F Asenjo, MD 514-934-1934 ext 43261

Canada, Quebec
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Principal Investigator: Juan F Asenjo, MD         
Sponsors and Collaborators
McGill University Health Center
Principal Investigator: Juan F Asenjo, MD Montreal General Hospital
  More Information

Publications: Identifier: NCT00294151     History of Changes
Other Study ID Numbers: GEN#05-015
Study First Received: February 17, 2006
Last Updated: July 12, 2007

Keywords provided by McGill University Health Center:
breast cancer
prostate cancer
vertebral metastasis
vertebral metastasis from breast cancer
vertebral metastasis from prostate cancer

Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplasms by Site
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes processed this record on April 27, 2017