Metastatic Cancer, Pain
Conditions
Keywords
bone metastases, pain
Brief summary
RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells and may help to relieve pain caused by bone metastases. PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in relieving pain in patients who have bone metastases.
Detailed description
OBJECTIVES: * Determine the efficacy of radiofrequency ablation, in terms of pain relief at 4 weeks, in patients with painful bone metastases. * Determine the safety of this regimen in these patients. * Compare the change in pain interference with daily life and analgesic use at 4 weeks vs baseline in patients treated with this regimen. * Determine the time to recurrence of worst pain in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive radiofrequency ablation (RFA) to targeted tumor(s) on day 0 (multiple tumors may receive ablation in multiple sessions). Patients who achieve a reduction in worst pain of at least 2 points within 4-8 weeks but experience recurring pain at the RFA site or are diagnosed with a new painful lesion within 4-24 weeks receive 1 additional treatment to the recurring or new site. Pain (using the Brief Pain Inventory scale of 0-10), analgesic use, and quality of life are assessed at baseline, on day 1, weekly for 4 weeks, and then every 2 weeks for 20 weeks. Patients are followed for 6 months beyond the last RFA treatment. PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
Interventions
PROCEDUREpain therapy
PROCEDUREradiofrequency ablation
Sponsors
Mayo Clinic
Study design
Primary purpose
SUPPORTIVE_CARE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed bone metastases * Pain refractory to non-opioid analgesic medication and radiotherapy OR * Patient is considered a poor candidate for opioid analgesics or radiotherapy * Initial worst pain score within the past 24 hours at least 4 on a scale of 0-10 * Tumors deemed accessible for radiofrequency ablation * No evidence of impending fracture in weight-bearing bones (more than 50% loss of cortical bone) * Tumors must be more than 1 cm from critical structures including: * Spinal cord, brain, or other critical nerve structures * Large abdominal vessel (e.g., aorta or inferior vena cava) * Bowel or bladder PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * More than 2 months Hematopoietic: * Platelet count at least 75,000/mm3 Hepatic: * INR less than 1.5 Renal: * Not specified Other: * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 3 weeks since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 3 weeks since prior radiotherapy Surgery: * Not specified Other: * At least 3 days since prior aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs * No concurrent anticoagulants
Countries
United States
Outcome results
None listed