CancerCAFENCT00211237
CAFE Study - Cancer Patient Fracture Evaluation
A study testing Balloon Kyphoplasty and Non Surgical Management in people with Cancer and Spinal Fractures, run by Medtronic Spine LLC at 20 sites in 8 countries.
Trial summary
The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared to standard non-surgical therapy in patients with cancer. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer, Spinal Fractures
- What is being tested?
- Balloon Kyphoplasty and Non Surgical Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 20 sitesin 8 countries
- Study dates
- May 2005to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One to 3 painful (pain on palpation/percussion over fractured vertebral body) VCF(s), T5-L5, with either bone marrow edema imaged by magnetic resonance imaging (MRI) or a fracture imaged by plain radiographs using the method of Genant
- Pain NRS score ≥4 on a scale of 0 to 10
- When the patient is newly diagnosed with multiple myeloma, the pain assessment must not be done until after completion of at least one pulse of steroid therapy or one week after the initiation of active multiple myeloma therapy.
- Roland Morris Disability Questionnaire score ≥ 10 on a scale of 0 to 24
- Patients must be at least 21 years old.
- No change in chemotherapy regimen (change in dose(s) permitted) for 1 month prior to enrollment
Show all 12Show fewer
- No change in chemotherapy regimen (change in dose(s) permitted) planned for at least 1 month following enrollment
- No major surgery to the spine planned for at least 1 month following enrollment
- Life expectancy of ≥ 3 months
- Patient has sufficient mental capacity to comply with the protocol requirements
- Patient has stated availability for all study visits
- Patient is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent.
Who cannot join
- Patients with primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma at site of the index VCF. Patients with these tumors in anatomic sites other than the index VCF are eligible.
- Concurrent Phase I investigational anti-cancer treatment
- Significant clinical morbidities (aside from the index fracture(s) and cancer) that may potentially interfere with the collection of data concerning pain and function
- VCF morphology deemed unsuitable for balloon kyphoplasty
- Additional non-kyphoplasty surgical treatment is required for the index fracture
- Patients requiring the use of high-dose steroid (≥ 100 mg prednisone or 20 mg dexamethasone per day), intravenous (IV) pain medication, or nerve block to control chronic back pain unrelated to index VCF(s). Patients who receive high-dose steroids for treatment of their cancer (for at least 30 days) are eligible.
Show all 19Show fewer
- Patients with a platelet count of < 20,000 measured at the time of hospital admission for the procedure
- Spinal cord compression or canal compromise requiring decompression
- Patients with osteoblastic tumors at the site of index VCF. Patients with osteoblastic tumors outside of vertebral levels intended for kyphoplasty may be enrolled.
- Medical/surgical conditions contrary to the balloon kyphoplasty procedure (e.g., in the presence of active or incompletely treated local infection)
- Known allergy to bone cement or contrast medium used in the treatment of study subjects
- MRI contraindication (e.g., cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis)
- Positive baseline pregnancy test (for women of child-bearing potential)
- Patients who may require allogeneic bone marrow transplantation during the course of the study.
- Other Reasons for Lack of Enrollment:
- Patient is afraid to have surgery
- Patient is afraid to have anesthesia
- Patient/family is not willing to participate in research
- Patient is not willing to be randomized
Trial locations and contacts
20 sites in 8 countries.
20 sites in 8 countries
United States9 sites
Boulder Neurosurgical Associates
Boulder, Colorado, 80304
Sibley Memorial Hospital
Chevy Chase, Maryland, 20815
Cleveland Clinic
Cleveland, Ohio, 44195
Karmanos Cancer Center
Detroit, Michigan, 48201
Valley Radiology Inc., UCSD
Escondido, California, 92025
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Utah
Salt Lake City, Utah, 84132
Greater Oncology Associates
Silver Spring, Maryland, 20910
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
Canada3 sites
Foothills Hospital
Calgary, Alberta, T2N2T9
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Australia2 sites
St. Vincent's Hospital
Fitzroy, Victoria, 3065
The Alfred Hospital
Melbourne, Victoria, 3004
About this study
Official title: A Multicenter, Prospective, Randomized, Controlled Study to Compare Balloon Kyphoplasty to Non-surgical Fracture Management in the Treatment of Painful, Acute Vertebral Body Compression Fractures in Cancer Patients
The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared to standard non-surgical therapy in patients with cancer.
Read the detailed description
- STUDY OBJECTIVES AND ENDPOINTS
1.1. Objectives
The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, VCFs as compared to standard non-surgical therapy in patients with cancer.
1.2. Primary Endpoint
The primary endpoint of the study is the improvement in functional status, as measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 month. The primary hypothesis of the study is that the mean improvement will be larger in subjects initially assigned to management with balloon kyphoplasty. Note that all subjects will undergo 12 months of follow-up after initial treatment assignment.
1.3. Secondary Endpoints
The following secondary endpoints will also be examined. Comparisons will be made at each follow-up visit.
Safety:
- Rate of study treatment-related adverse events
- Change in neurological status
Clinical:
- Change in functional status as assessed with Karnofsky Performance Scale
- Change in quality of life as assessed by the SF-36v2™ Health Survey
- Change in back pain, as measured by a 10-point Numerical Rating Scale (NRS)
- Change in back-pain analgesics used
- Change in ambulation status
- Changes in activities of daily living
- Time to treatment failure
Radiographic:
- Change in spinal deformity, defined as the degree of spine angulation as assessed by an independent radiologist at the core laboratory
- Rate of subsequent vertebral body fractures, as assessed by independent radiologists at the core lab
In each case, the study hypothesis is that treatment with balloon kyphoplasty will result in an improvement in clinical or radiographic outcomes compared to baseline and compared to non-surgical treatment, with a preservation of outcomes in long-term follow-up.
- Conditions
- Cancer, Spinal Fractures
- Being tested
- Balloon Kyphoplasty, Non Surgical Management
- Keywords
- Balloon Kyphoplasty, Cancer, Vertebral Compression Fracture, Back Pain, Spine
- Medical subject headings
- Neoplasms, Spinal Fractures, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon KyphoplastyDevice
Also called KyphX Inflatable Bone Tamps
Ballon Kyphoplasty is a minimally invasive technique aimed at reduction of VCFs using KyphX® Inflatable Bone Tamps followed by fracture fixation with KyphX® HV-R™ Bone Cement.
Non Surgical ManagementOther
Non-surgical treatment includes, but is not limited to, the following: back brace, pain medication, physical therapy, walking aids, bed rest, and radiation treatment.
| Study group | Role | What they receive |
|---|---|---|
| Balloon Kyphoplasty (BKP) | Experimental | The subjects assigned to this group will undergo the treatment with Balloon kyphoplasty for their painful VCFs. Receives: Device: Balloon Kyphoplasty |
| Non Surgical Management | Active comparator | The subjects in this group will undergo the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Receives: Other: Non Surgical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month
The full scale name is the Roland-Morris Disability Questionnaire; it is a validated measure of physical disability due to back pain.
The best score is 0 (no disability) and worst is 24 (maximum disability)
Measured: Baseline and 1 Month
Secondary outcomes (33)
Change in Roland-Morris Disability Questionnaire Score
Roland-Morris Disability Questionnaire (RMDQ) was used to assess the physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability).
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months
Change in Functional Status Assessed With the Karnofsky Performance Scale
The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).
Measured: Baseline and 1 month
Change in Functional Status Assessed With the Karnofsky Performance Scale
The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months
Change in Back Pain
Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).
Measured: Baseline and 1 month
Change in Back Pain
Back pain was assessed on a NRS from 0 (no pain) to 10 (worst possible pain).
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months
Change in Quality of Life.
The SF-36 was used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.
Measured: Baseline and 1 month
Change in Quality of Life
The SF-36 were used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Measured: Baseline and 1 month
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months
Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks
The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Measured: Baseline and 1 month
Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks
The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months
Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks
The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Measured: Baseline and 1 month
Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks
The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months
Ambulatory Status Change From Baseline to One Month
Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.
Measured: 1 month
Ambulatory Status Change
Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.
Measured: Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months
Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month
Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.
Measured: Baseline and 1 month
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.
Measured: Baseline, post-operation, 1 month, and 12 months
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.
Measured: Baseline and 1 month
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.
Measured: Baseline, post-operation, 1 month, and 12 months
Back Pain Analgesics Used
Measured: Baseline, 7 days, and 1 month
Back Pain Analgesics Used
Measured: Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months
Change in Neurology Status From Baseline (Motor Strength)
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following:
absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5
Measured: 1 month
Change in Neurology Status From Baseline (Motor Strength)-Per Protocol
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following:
absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5
Measured: 1 month, 3 months, 6 months, and 12 months
Change in Neurological Status From Baseline (Sensory Examination)
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.
Measured: 1 month
Change in Neurological Status From Baseline (Sensory Examination)
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.
Measured: 1 months, 3 months, 6 months, and 12 months
Change in Neurological Status From Baseline (Reflex Strength)
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following:
absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3
Measured: 1 month
Change in Neurological Status From Baseline (Reflex Strength)
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following:
absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3
Measured: 1 months, 3 months, 6 months, and 12 months
Change in Neurological Status From Baseline (Limb Strength)
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).
Measured: 1 month
Change in Neurological Status From Baseline (Limb Strength)
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).
Measured: 1 months, 3 months, 6 months, and 12 months
Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline
The study treatment-related AEs were defined as follows:
- Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient.
- Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated.
- Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device.
- Unknown defined as the relationship of the AE to a Sponsor device could not be determined.
Measured: 1 month
Rate of Study Treatment-related Adverse Events Till Study Completion
The study treatment-related AEs were defined as follows:
- Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient.
- Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated.
- Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device.
- Unknown defined as the relationship of the AE to a Sponsor device could not be determined.
Measured: 12 months
Rate of Subsequent Vertebral Body Fractures
Measured: 1 month
Rate of Subsequent Vertebral Body Fractures
Based on patients with at least 7 analyzable vertebrae.
Measured: 1 month and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionApr 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spine LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Berenson, M.D., Principal investigator, Institute for Myeloma & Bone Cancer ResearchFrank Vrionis, M.D., Principal investigator, H. Lee Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211237
- Sponsor's protocol ID
- SP0401 - CAFE Study
- Acronym
- CAFE
- Status last verified
- Jun 2017
- First submitted
- 13 Sep 2005
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Berenson J, Pflugmacher R, Jarzem P, Zonder J, Schechtman K, Tillman JB, Bastian L, Ashraf T, Vrionis F; Cancer Patient Fracture Evaluation (CAFE) Investigators. Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial. Lancet Oncol. 2011 Mar;12(3):225-35. doi: 10.1016/S1470-2045(11)70008-0. Epub 2011 Feb 16.
PubMed 21333599
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Controlled Study to Compare Balloon Kyphoplasty to Non-surgical Fracture Management in the Treatment of Painful, Acute Vertebral Body Compression Fractures in Cancer Patients
- ClinicalTrials.gov ID
- NCT00211237
- Acronym / sponsor ID
- CAFE / SP0401 - CAFE Study
- Conditions
- Cancer, Spinal Fractures
- Keywords
- Balloon Kyphoplasty, Cancer, Vertebral Compression Fracture, Back Pain, Spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Medtronic Spine LLCIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 14 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared to standard non-surgical therapy in patients with cancer.
Detailed description
- STUDY OBJECTIVES AND ENDPOINTS
1.1. Objectives
The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, VCFs as compared to standard non-surgical therapy in patients with cancer.
1.2. Primary Endpoint
The primary endpoint of the study is the improvement in functional status, as measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 month. The primary hypothesis of the study is that the mean improvement will be larger in subjects initially assigned to management with balloon kyphoplasty. Note that all subjects will undergo 12 months of follow-up after initial treatment assignment.
1.3. Secondary Endpoints
The following secondary endpoints will also be examined. Comparisons will be made at each follow-up visit.
Safety:
- Rate of study treatment-related adverse events
- Change in neurological status
Clinical:
- Change in functional status as assessed with Karnofsky Performance Scale
- Change in quality of life as assessed by the SF-36v2™ Health Survey
- Change in back pain, as measured by a 10-point Numerical Rating Scale (NRS)
- Change in back-pain analgesics used
- Change in ambulation status
- Changes in activities of daily living
- Time to treatment failure
Radiographic:
- Change in spinal deformity, defined as the degree of spine angulation as assessed by an independent radiologist at the core laboratory
- Rate of subsequent vertebral body fractures, as assessed by independent radiologists at the core lab
In each case, the study hypothesis is that treatment with balloon kyphoplasty will result in an improvement in clinical or radiographic outcomes compared to baseline and compared to non-surgical treatment, with a preservation of outcomes in long-term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon Kyphoplasty (BKP) | Experimental | Device: Balloon KyphoplastyThe subjects assigned to this group will undergo the treatment with Balloon kyphoplasty for their painful VCFs. |
| Non Surgical Management | Active comparator | Other: Non Surgical ManagementThe subjects in this group will undergo the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- One to 3 painful (pain on palpation/percussion over fractured vertebral body) VCF(s), T5-L5, with either bone marrow edema imaged by magnetic resonance imaging (MRI) or a fracture imaged by plain radiographs using the method of Genant
- Pain NRS score ≥4 on a scale of 0 to 10
- Roland Morris Disability Questionnaire score ≥ 10 on a scale of 0 to 24
- Patients must be at least 21 years old.
- No change in chemotherapy regimen (change in dose(s) permitted) for 1 month prior to enrollment
Key exclusion criteria (19 listed)
- Patients with primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma at site of the index VCF. Patients with these tumors in anatomic sites other than the index VCF are eligible.
- Concurrent Phase I investigational anti-cancer treatment
- Significant clinical morbidities (aside from the index fracture(s) and cancer) that may potentially interfere with the collection of data concerning pain and function
- VCF morphology deemed unsuitable for balloon kyphoplasty
- Additional non-kyphoplasty surgical treatment is required for the index fracture
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 |
|---|---|---|
| Balloon KyphoplastyAlso: KyphX Inflatable Bone TampsBallon Kyphoplasty is a minimally invasive technique aimed at reduction of VCFs using KyphX® Inflatable Bone Tamps followed by fracture fixation with KyphX® HV-R™ Bone Cement. | Device | Balloon Kyphoplasty (BKP) |
| Non Surgical ManagementNon-surgical treatment includes, but is not limited to, the following: back brace, pain medication, physical therapy, walking aids, bed rest, and radiation treatment. | Other | Non Surgical Management |
Primary outcome
The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month
Time frame: Baseline and 1 Month
The full scale name is the Roland-Morris Disability Questionnaire; it is a validated measure of physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability)
33 secondary outcomes
Change in Roland-Morris Disability Questionnaire Score
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Change in Functional Status Assessed With the Karnofsky Performance Scale
Time frame: Baseline and 1 month
Change in Functional Status Assessed With the Karnofsky Performance Scale
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Change in Back Pain
Time frame: Baseline and 1 month
Change in Back Pain
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Change in Quality of Life.
Time frame: Baseline and 1 month
Change in Quality of Life
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
Time frame: Baseline and 1 month
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks
Time frame: Baseline and 1 month
Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks
Time frame: Baseline and 1 month
Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Ambulatory Status Change From Baseline to One Month
Time frame: 1 month
Ambulatory Status Change
Time frame: Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months
Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month
Time frame: Baseline and 1 month
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Time frame: Baseline, post-operation, 1 month, and 12 months
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Time frame: Baseline and 1 month
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Time frame: Baseline, post-operation, 1 month, and 12 months
Back Pain Analgesics Used
Time frame: Baseline, 7 days, and 1 month
Back Pain Analgesics Used
Time frame: Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months
Change in Neurology Status From Baseline (Motor Strength)
Time frame: 1 month
Change in Neurology Status From Baseline (Motor Strength)-Per Protocol
Time frame: 1 month, 3 months, 6 months, and 12 months
Change in Neurological Status From Baseline (Sensory Examination)
Time frame: 1 month
Change in Neurological Status From Baseline (Sensory Examination)
Time frame: 1 months, 3 months, 6 months, and 12 months
Change in Neurological Status From Baseline (Reflex Strength)
Time frame: 1 month
Change in Neurological Status From Baseline (Reflex Strength)
Time frame: 1 months, 3 months, 6 months, and 12 months
Change in Neurological Status From Baseline (Limb Strength)
Time frame: 1 month
Change in Neurological Status From Baseline (Limb Strength)
Time frame: 1 months, 3 months, 6 months, and 12 months
Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline
Time frame: 1 month
Rate of Study Treatment-related Adverse Events Till Study Completion
Time frame: 12 months
Rate of Subsequent Vertebral Body Fractures
Time frame: 1 month
Rate of Subsequent Vertebral Body Fractures
Time frame: 1 month and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21333599Berenson J, Pflugmacher R, Jarzem P, Zonder J, Schechtman K, Tillman JB, Bastian L, Ashraf T, Vrionis F; Cancer Patient Fracture Evaluation (CAFE) Investigators. Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial. Lancet Oncol. 2011 Mar;12(3):225-35. doi: 10.1016/S1470-2045(11)70008-0. Epub 2011 Feb 16.
Related trials for Cancer
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
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.
James Berenson, M.D. principal investigator
Institute for Myeloma & Bone Cancer Research
Frank Vrionis, M.D. principal investigator
H. Lee Moffitt Cancer Center
20 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon Kyphoplasty and Non Surgical Management in people with Cancer and Spinal Fractures, run by Medtronic Spine LLC at 20 sites in 8 countries.
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 12 inclusion and 19 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: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Canada, Australia, Germany, Belgium and 3 more countries. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month (time frame: Baseline and 1 Month). 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 NCT00211237, which also lists 1 linked publication.
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 5 Jan 2021.