Percutaneous Cryoablation in Treating Patients With Painful Bone Metastases

Pain Clinical Trial

Official title:

Percutaneous US and CT-guided Cryoablation of Painful Metastases Involving Bone: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608855
• Other study ID #: MC03C3
• Secondary ID: MAYO-MC03C3
• Status: Completed
• Phase: N/A
• First received: February 1, 2008
• Last updated: January 11, 2017
• Start date: November 2003
• Est. completion date: February 2013

Study information

• Verified date: January 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed metastatic solid tumor involving or abutting bone (index lesion)

• If the nature of the metastatic disease has been previously documented, index lesion to be treated does not require further documentation (i.e., biopsy)

• Pain either refractory to standard care (chemotherapy, radiotherapy, surgery, or analgesics) or patient is considered a poor candidate for conventional therapies

• Radiation oncology consult is required if the patient is considered clinically to be a candidate for conventional palliative radiotherapy

• Surgical oncology consult is required if the patient is considered clinically to be a candidate for conventional surgical treatment or is considered at risk for complications resulting from potential fracture

• Initial pain score = 4 on a scale of 0-10 for the question "Please rate your pain by circling the one number that best describes your pain at its worst in the past 24 hours" on the Cleeland Brief Pain Inventory

• Pain from = 2 sites of metastatic disease

• No lesions with evidence for impending fracture involving a weight-bearing bone (> 50% loss of cortical bone at the site)

PATIENT CHARACTERISTICS:

• Life expectancy = 2 months

• Platelet count = 75,000/mm³

• ANC > 1,500/mm³ (for patients who have recently been treated with chemotherapy)

• INR = 1.2

• Not pregnant or nursing

• Negative pregnancy test

PRIOR CONCURRENT THERAPY:

• More than 3 weeks since prior radiotherapy

• More than 3 weeks since initiation of a new chemotherapy regimen, including bisphosphonates

• More than 7 days since prior antiplatelet medications or clopidogrel

• More than 3 days since prior acetylsalicylic acid (aspirin), ibuprofen, or other NSAIDs

• No prior treatment of the portion of a lesion within 0.5 cm of the spinal cord or brain, within 0.5 cm of a large abdominal vessel such as the aorta or inferior vena cava, or within 1 cm of bowel or bladder

• No prior radiofrequency ablation for pain palliation of the same lesion

• No concurrent regular or low molecular weight heparin or other anticoagulants

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Pain
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Other:
• questionnaire administration

Procedure:
• cryosurgery

• pain therapy

• quality-of-life assessment

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin
United States	Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	NYU Cancer Institute at New York University Medical 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	Mayo Clinic Cancer Center	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8			No
Secondary	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			No
Secondary	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			No
Secondary	Percentage of patients who are able to reduce analgesic medications			No