Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases
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.
Procedure: pain therapy
Procedure: radiofrequency ablation
|Study Design:||Primary Purpose: Supportive Care|
|Official Title:||RF Ablation of Painful Metastases Involving Bone|
|Study Start Date:||October 2000|
|Primary Completion Date:||October 2002 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00029029
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21287|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|United States, Wisconsin|
|St. Luke's Medical Center|
|Milwaukee, Wisconsin, United States, 53215|
|Study Chair:||J. William Charboneau, MD||Mayo Clinic|