Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases
- Conditions
- PainMetastatic Cancer
- Registration Number
- NCT00029029
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States