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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 because the information has not been verified recently.
Verified January 2006 by McGill University Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00294151
First received: February 17, 2006
Last updated: July 12, 2007
Last verified: January 2006
History of Changes
  Purpose

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
Pain
 Procedure: Vertebroplasty
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00294151

Contacts
Contact: Juan F Asenjo, MD 514-934-1934 ext 43261 jfasenjog@yahoo.com

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

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

ClinicalTrials.gov Identifier: NCT00294151     History of Changes
Other Study ID Numbers: GEN#05-015
Study First Received: February 17, 2006
Last Updated: July 12, 2007
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013