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

NCT ID: NCT00294151

Last Updated: 2007-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer Prostate Cancer Vertebral Metastasis Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Vertebroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Principal Investigators

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Juan F Asenjo, MD

Role: PRINCIPAL_INVESTIGATOR

Montreal General Hospital

Locations

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Montreal General Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Juan F Asenjo, MD

Role: CONTACT

[email protected]
514-934-1934 ext. 43261

References

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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.

Reference Type BACKGROUND
PMID: 12160506 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11899906 (View on PubMed)

McQuay HJ. The Cochrane Database of Systematic Reviews 3:---,2003.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 14527699 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12865843 (View on PubMed)

Other Identifiers

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GEN#05-015

Identifier Type: -

Identifier Source: org_study_id