NCT00041886

Radiofrequency Ablation of Painful Soft Tissue Neoplasms

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (planned)
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Radiofrequency ablation is used to treat patients with many different conditions. It is used to treat heart arrhythmia and benign bone tumors, and to control bleeding during surgery. It has been approved by the Food and Drug Administration for soft tissue ablation (removal). The technique involves inserting a probe, guided by computed tomography or ultrasound, and sending radio waves through the probe. The radio waves generate heat, which both destroys adjacent tissue and cauterizes blood vessels. This study will enroll 15 adults (age 18 or older) with soft tissue metastases who suffer pain that is not well controlled by other means, such as drugs. The goal is to reduce their pain or their use of analgesics by partially destroying some of their tumors. Patients will be ineligible for the study if they change the class of pain medication they use within 2 weeks before or 2 weeks after the study treatment. Patients will fill out short questionnaires about pain and daily activities (Brief Pain Inventory) before treatment and 1 day, 1 week, 1 month, 3 months, and 12 months after treatment to ascertain whether their pain is better controlled with less pain medication. For the treatment, most patients will receive local anesthetic in the area where the probe is inserted. Some patients may require general anesthesia. The probe will remain in place typically for 10 to 30 minutes. For larger tumors, it may be inserted at different positions.

Detailed description

This study will examine the efficacy of using radiofrequency ablation (RFA) to treat pain soft tissue metastases not well controlled by conventional methods of treatment, defined as ongoing pain despite maximum pharmacologic interventions, or severe side effects like mental status alteration from medication. Prior experience with similar techniques in the liver, kidney, heart, bones, prostate, lymph nodes, brain, pancreas, and nerve ganglions has found that ablation of a specific volume of tissue with the application of RFA energy is safe and effective. We are hopeful that this method of tissue ablation could assist in the difficult management of patients with painful lesions. The goal will be to reduce pain, or to reduce use of analgesics. Any decrease in strength of opiate used, or in dose equivalent same-medication on a per week basis will be considered significant.

Conditions

• Soft Tissue Neoplasms

Timeline

• Start date: 2002-07-01
• Completion: 2005-06-01
• First posted: 2002-07-19
• Last updated: 2008-03-04

Locations

1 site across 1 country: United States