Clinical trial NCT00294151: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: 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
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2006-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: pain relief; score on pain questionnaire
timeFrame: at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
Secondary outcomes:
measure: quality of life; score on 2 quality of life questionnaires
timeFrame: at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
measure: pain medication
timeFrame: listed at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
measure: side effects
timeFrame: listed at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
measure: cost of medical care
timeFrame: evaluated at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
measure: survival
timeFrame: recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
measure: new vertebral fractures
timeFrame: recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: Montreal General Hospital
name: Juan F Asenjo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: McQuay HJ. The Cochrane Database of Systematic Reviews 3:---,2003.
citation: McLain R. Tumors of the Spine. In Herkowitz H et al. The Spine Philadelphia, WB Saunders Co 1171-1206, 1999.
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.
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.