Breast CancerPhase 3NCT00294151
Potential Vertebroplasty Use in the Treatment of Vertebral Metastasis From Breast and Prostate Cancer
A Phase 3 study testing Vertebroplasty in people with Breast Cancer and Prostate Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Vertebral Metastasis
- What is being tested?
- Vertebroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Juan F Asenjo, MD
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer, Prostate Cancer, Vertebral Metastasis, Pain
- Being tested
- Vertebroplasty
- Keywords
- breast cancer, prostate cancer, vertebral metastasis, vertebroplasty, vertebral metastasis from breast cancer, vertebral metastasis from prostate cancer
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VertebroplastyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief; score on pain questionnaire
Measured: at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
Secondary outcomes (6)
quality of life; score on 2 quality of life questionnaires
Measured: at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
pain medication
Measured: listed at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
side effects
Measured: listed at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
cost of medical care
Measured: evaluated at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
survival
Measured: recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
new vertebral fractures
Measured: recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Investigators
- Juan F Asenjo, MD, Principal investigator, Montreal General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294151
- Sponsor's protocol ID
- GEN#05-015
- Status last verified
- Jan 2006
- First submitted
- 17 Feb 2006
- Last updated
- 13 Jul 2007
- Results posted
- No
Publications
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.
PubMed 12160506Wu 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.
PubMed 11899906McQuay HJ. The Cochrane Database of Systematic Reviews 3:---,2003.
McLain R. Tumors of the Spine. In Herkowitz H et al. The Spine Philadelphia, WB Saunders Co 1171-1206, 1999.
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.
PubMed 14527699Molloy 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.
PubMed 12865843
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00294151
- Acronym / sponsor ID
- GEN#05-015
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Sep 2005
- First posted
- 20 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vertebroplasty | Procedure or surgery | – |
Primary outcome
pain relief; score on pain questionnaire
Time frame: at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
6 secondary outcomes
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
pain medication
Time frame: listed at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
side effects
Time frame: listed at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
cost of medical care
Time frame: evaluated at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
survival
Time frame: recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
new vertebral fractures
Time frame: recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2007.
- Background: PubMed 12160506Saarto 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.
- Background: PubMed 11899906Wu 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.
- BackgroundMcQuay HJ. The Cochrane Database of Systematic Reviews 3:---,2003.
- BackgroundMcLain R. Tumors of the Spine. In Herkowitz H et al. The Spine Philadelphia, WB Saunders Co 1171-1206, 1999.
- Background: PubMed 14527699Niv 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.
- Background: PubMed 12865843Molloy 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.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan F Asenjo, MD principal investigator
Montreal General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vertebroplasty in people with Breast Cancer and Prostate Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan F Asenjo, MD (514-934-1934 ext. 43261, jfasenjog@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain relief; score on pain questionnaire (time frame: at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00294151, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2007.