Recruiting
Phase 3

Vertebroplasty & Radiotherapy

Sponsor:

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

Code:

NCT00294151

Conditions

Breast Cancer

Prostate Cancer

Vertebral Metastasis

Pain

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Interventions

Vertebroplasty

Study Details

Brief 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.

Conditions

Breast Cancer

Prostate Cancer

Vertebral Metastasis

Pain

Study ID

NCT00294151

Start date

Sep, 2005

Status verified date

Jan, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Vertebroplasty

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Juan F Asenjo, MD

514-934-1934jfasenjog@yahoo.com

Locations

Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Principal Investigator:

Juan F Asenjo, MD

More Information

Sponsor

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

Last update posted

Jul 13, 2007

Last verified

Jan, 2006

Keywords

  • breast cancer
  • prostate cancer
  • vertebral metastasis
  • vertebroplasty
  • vertebral metastasis from breast cancer
  • vertebral metastasis from prostate cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2007-07-13.