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

July 12, 2007 updated by: McGill University Health Centre/Research Institute of the McGill University Health Centre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Recruiting
        • Montreal General Hospital
        • Principal Investigator:
          • Juan F Asenjo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain relief; score on pain questionnaire
Time Frame: at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: Juan F Asenjo, MD, Montreal General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Registration Dates

First Submitted

February 17, 2006

First Submitted That Met QC Criteria

February 17, 2006

First Posted (Estimate)

February 20, 2006

Study Record Updates

Last Update Posted (Estimate)

July 13, 2007

Last Update Submitted That Met QC Criteria

July 12, 2007

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEN#05-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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