Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases

Phase 2

Completed

• Conditions: Pain; Metastatic 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.

Study Timeline

• Study Start: 2000-10-13
• Study First Submitted: 2002-01-04
• Primary Completion: 2002-10-24
• Study Completion: 2002-10-24
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

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