CAFE Study - Cancer Patient Fracture Evaluation (NCT00211237) | Clinical Trial Compass
CompletedNot Applicable
CAFE Study - Cancer Patient Fracture Evaluation
United States, Australia, Belgium134 participantsStarted 2005-05
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. 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
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month
. 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.
. 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