Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00029029
Recruitment Status : Unknown
Verified January 2016 by Mayo Clinic.
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : May 25, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Pain Procedure: pain therapy Procedure: radiofrequency ablation Phase 2

Detailed Description:


  • 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 Type : Interventional  (Clinical Trial)
Primary Purpose: Supportive Care
Official Title: RF Ablation of Painful Metastases Involving Bone
Study Start Date : October 2000
Primary Completion Date : October 2002

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • More than 2 months


  • Platelet count at least 75,000/mm3


  • INR less than 1.5


  • Not specified


  • Not pregnant or nursing
  • Negative pregnancy test


Biologic therapy:

  • Not specified


  • At least 3 weeks since prior chemotherapy

Endocrine therapy:

  • Not specified


  • At least 3 weeks since prior radiotherapy


  • Not specified


  • At least 3 days since prior aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs
  • No concurrent anticoagulants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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
Sponsors and Collaborators
Mayo Clinic
Study Chair: J. William Charboneau, MD Mayo Clinic

Responsible Party: Mayo Clinic Identifier: NCT00029029     History of Changes
Other Study ID Numbers: CDR0000069180
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mayo Clinic:
bone metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes