Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT00294151
Status:
UNKNOWN
Last Update Posted:
2007-07-13
First Post:
2006-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Potential Vertebroplasty Use in the Treatment of Vertebral Metastasis From Breast and Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054854', 'term': 'Vertebroplasty'}], 'ancestors': [{'id': 'D060826', 'term': 'Cementoplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-01', 'lastUpdateSubmitDate': '2007-07-12', 'studyFirstSubmitDate': '2006-02-17', 'studyFirstSubmitQcDate': '2006-02-17', 'lastUpdatePostDateStruct': {'date': '2007-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain relief; score on pain questionnaire', 'timeFrame': 'at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after'}], 'secondaryOutcomes': [{'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'}]}, 'conditionsModule': {'keywords': ['breast cancer', 'prostate cancer', 'vertebral metastasis', 'vertebroplasty', 'vertebral metastasis from breast cancer', 'vertebral metastasis from prostate cancer'], 'conditions': ['Breast Cancer', 'Prostate Cancer', 'Vertebral Metastasis', 'Pain']}, 'referencesModule': {'references': [{'pmid': '12160506', 'type': 'BACKGROUND', '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.'}, {'pmid': '11899906', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', 'citation': 'McQuay HJ. The Cochrane Database of Systematic Reviews 3:---,2003.'}, {'type': 'BACKGROUND', 'citation': 'McLain R. Tumors of the Spine. In Herkowitz H et al. The Spine Philadelphia, WB Saunders Co 1171-1206, 1999.'}, {'pmid': '14527699', 'type': 'BACKGROUND', '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.'}, {'pmid': '12865843', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThere 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 35 and 75 years old\n* Biopsy-proven breast cancer (BC) or prostate cancer (PC)\n* Radiographic evidence of spine metastases from the BC or PC in the lumbar and/or mid-low thoracic spine\n* 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)\n* Incidental back pain (Verbal Analog Scale \\> 5/10) felt to be related to those metastases\n\nExclusion Criteria:\n\n* Spinal cord compression\n* Massive rupture of the posterior wall of the vertebral body (according to blinded radiological report)\n* Coagulopathy (International Normalized Ratio \\[INR\\] \\> 1.5, platelets \\< 80,000)\n* Inability to communicate in English, French or Spanish\n* Previous radiotherapy to the spine in the area presently affected\n* Mental cognitive impairment\n* Vertebral metastasis without fracture in the MRI'}, 'identificationModule': {'nctId': 'NCT00294151', 'briefTitle': 'Potential Vertebroplasty Use in the Treatment of Vertebral Metastasis From Breast and Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'GEN#05-015'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Vertebroplasty', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Juan F Asenjo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Montreal General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Juan F Asenjo, MD', 'role': 'CONTACT', 'email': 'jfasenjog@yahoo.com', 'phone': '514-934-1934', 'phoneExt': '43261'}], 'overallOfficials': [{'name': 'Juan F Asenjo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montreal General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}}}}