Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases

Pain Clinical Trial

Official title:

RF Ablation of Painful Metastases Involving Bone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00029029
• Other study ID #: CDR0000069180
• Secondary ID: RITA-201-00MAYO-
• Status: Completed
• Phase: Phase 2
• Start date: October 13, 2000
• Est. completion date: October 24, 2002

Study information

• Verified date: August 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 24, 2002
• Est. primary completion date: October 24, 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• More than 2 months

Hematopoietic:

• Platelet count at least 75,000/mm3

Hepatic:

• INR less than 1.5

Renal:

• Not specified

Other:

• Not pregnant or nursing

• Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 3 weeks since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 3 weeks since prior radiotherapy

Surgery:

• Not specified

Other:

• At least 3 days since prior aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs

• No concurrent anticoagulants

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Pain

Intervention

Procedure:
• pain therapy

• radiofrequency ablation

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Mayo Clinic Cancer Center	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States,