Pain Clinical Trial
Official title:
RF Ablation of Painful Metastases Involving Bone
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.
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.
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