Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Metastatic Cancer; Pain

Treatments: Procedure: radiofrequency ablation; Procedure: pain therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00029029

RITA-IDE-G000177

MDA-ID-01534

CDR0000069180

RITA-201-00

MAYO-IRB-O-1223-00

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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