CAFE Study - Cancer Patient Fracture Evaluation (NCT00211237) | Clinical Trial Compass
CompletedNot Applicable
CAFE Study - Cancer Patient Fracture Evaluation
United States134 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 range21 Years
SexALL
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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.
✕. 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
✕
What they're measuring
1
The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month
. 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