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

Primary Purpose

Breast Cancer, Prostate Cancer, Vertebral Metastasis

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Vertebroplasty
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, prostate cancer, vertebral metastasis, vertebroplasty, vertebral metastasis from breast cancer, vertebral metastasis from prostate cancer

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montreal General HospitalRecruiting

Outcomes

Primary Outcome Measures

pain relief; score on pain questionnaire

Secondary Outcome Measures

quality of life; score on 2 quality of life questionnaires
pain medication
side effects
cost of medical care
survival
new vertebral fractures

Full Information

First Posted
February 17, 2006
Last Updated
July 12, 2007
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00294151
Brief Title
Potential Vertebroplasty Use in the Treatment of Vertebral Metastasis From Breast and Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Prostate Cancer, Vertebral Metastasis, Pain
Keywords
breast cancer, prostate cancer, vertebral metastasis, vertebroplasty, vertebral metastasis from breast cancer, vertebral metastasis from prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Vertebroplasty
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
pain medication
Time Frame
listed at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
Title
side effects
Time Frame
listed at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
Title
cost of medical care
Time Frame
evaluated at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
Title
survival
Time Frame
recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
Title
new vertebral fractures
Time Frame
recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan F Asenjo, MD
Phone
514-934-1934
Ext
43261
Email
jfasenjog@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan F Asenjo, MD
Organizational Affiliation
Montreal General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan F Asenjo, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
12160506
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. doi: 10.1016/s1090-3801(02)00028-9.
Results Reference
background
PubMed Identifier
11899906
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. doi: 10.1053/clon.2001.0012.
Results Reference
background
Citation
McQuay HJ. The Cochrane Database of Systematic Reviews 3:---,2003.
Results Reference
background
Citation
McLain R. Tumors of the Spine. In Herkowitz H et al. The Spine Philadelphia, WB Saunders Co 1171-1206, 1999.
Results Reference
background
PubMed Identifier
14527699
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):387-392. doi: 10.1016/S0304-3959(03)00277-X.
Results Reference
background
PubMed Identifier
12865843
Citation
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.
Results Reference
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Potential Vertebroplasty Use in the Treatment of Vertebral Metastasis From Breast and Prostate Cancer

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