Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases

NCT00029029 | Completed Phase 2

• 5 other identifiers: CDR0000069180RITA-201-00MAYO-IRB-O-1223-00MDA-ID-01534RITA-IDE-G000177
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

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.

Conditions

Metastatic Cancer; Pain

Keywords

bone metastases; pain

Interventions

pain therapy PROCEDURE

radiofrequency ablation PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (6)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Pain

Interventions

Analgesia; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• J. William Charboneau, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2002
• First Posted: January 27, 2003
• Study Start: October 13, 2000
• Primary Completion: October 24, 2002
• Study Completion: October 24, 2002
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)