RATIONALE: Percutaneous cryoablation may help relieve pain caused by bone metastases. PURPOSE: This clinical trial is studying the side effects and how well percutaneous cryoablation works in treating patients with painful bone metastases.
OBJECTIVES: * To confirm the safety of percutaneous cryoablation in the palliative treatment of patients with painful bone metastases. * To determine the benefits of cryoablation of painful bone metastases by assessing pain intensity using a standardized Cleeland Brief Pain Inventory (BPI) and quality of life using a standardized SF-8 both before and after treatment. * To determine the secondary benefits of cryoablation of painful bone metastases by assessing change in analgesic use following therapy. * To determine the level of anesthesia required for cryoablation with a baseline level of conscious sedation planned for each treatment. OUTLINE: This is a multicenter study. Patients undergo percutaneous cryoablation to one or two sites of metastatic disease using the Endocare Cryocare system. Patients with a good initial response to treatment (≥ 2 decrease in pain intensity rating on the Brief Pain Inventory) who develop recurrent pain at the same site or a new painful site ≥ 1 month after initial treatment may undergo one additional cryoablation treatment. Patients complete pain and quality of life questionnaires periodically. After completion of study treatment, patients are followed periodically for 2 years.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8
Average difference in pre- and post-treatment worst pain score in a 24-hour period, average pain score, and pain relief score at 6, 12, and 24 months
Average amount of pain per patient over the observation period as represented by the area under the curve (AUC) constructed from weekly pain scores on a visual-analogue scale using a score of 0-10
Percentage of patients who are able to reduce analgesic medications
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