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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

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

NCT ID

NCT00294151

First Posted

February 17, 2006

Last Updated

July 12, 2007

Sponsor

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

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

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Juan F Asenjo, MD

Phone

514-934-1934

Ext

43261

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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