Percutaneous Cryoablation in Treating Patients With Painful Bone Metastases

Not Applicable

Completed

• Conditions: Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific; Pain

• Registration Number: NCT00608855
• Lead Sponsor: Mayo Clinic

Brief Summary

RATIONALE: Percutaneous cryoablation may help relieve pain caused by bone metastases.

PURPOSE: This clinical trial is studying the side effects and how well percutaneous cryoablation works in treating patients with painful bone metastases.

Detailed Description

OBJECTIVES:

* To confirm the safety of percutaneous cryoablation in the palliative treatment of patients with painful bone metastases.

* To determine the benefits of cryoablation of painful bone metastases by assessing pain intensity using a standardized Cleeland Brief Pain Inventory (BPI) and quality of life using a standardized SF-8 both before and after treatment.

* To determine the secondary benefits of cryoablation of painful bone metastases by assessing change in analgesic use following therapy.

* To determine the level of anesthesia required for cryoablation with a baseline level of conscious sedation planned for each treatment.

OUTLINE: This is a multicenter study.

Patients undergo percutaneous cryoablation to one or two sites of metastatic disease using the Endocare Cryocare system. Patients with a good initial response to treatment (≥ 2 decrease in pain intensity rating on the Brief Pain Inventory) who develop recurrent pain at the same site or a new painful site ≥ 1 month after initial treatment may undergo one additional cryoablation treatment.

Patients complete pain and quality of life questionnaires periodically.

After completion of study treatment, patients are followed periodically for 2 years.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2008-02-01
• Study First Submitted QC: 2008-02-01
• Study First Posted: 2008-02-06
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8

Secondary Outcome Measures

Name	Time	Method
Average difference in pre- and post-treatment worst pain score in a 24-hour period, average pain score, and pain relief score at 6, 12, and 24 months
Average amount of pain per patient over the observation period as represented by the area under the curve (AUC) constructed from weekly pain scores on a visual-analogue scale using a score of 0-10
Percentage of patients who are able to reduce analgesic medications

Trial Locations

Locations (10)

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

Mayo Clinic - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

NYU Cancer Institute at New York University Medical Center; 🇺🇸 New York, New York, United States

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Brown University School of Medicine; 🇺🇸 Providence, Rhode Island, United States

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center; 🇺🇸 Madison, Wisconsin, United States

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States