Questionnaire administration and quality-of-life assessment and pain therapy in Pain and Unspecified Adult Solid Tumor, Protocol Specific and Metastatic Cancer - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Florida
  - Jacksonville, Florida, United States, 32224
    - Mayo Clinic - Jacksonville
- Michigan
  - Ann Arbor, Michigan, United States, 48109-0942
    - University Of Michigan Comprehensive Cancer Center
  - Detroit, Michigan, United States, 48201-1379
    - Barbara Ann Karmanos Cancer Institute
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic Cancer Center
- New York
  - New York, New York, United States, 10021
    - Memorial Sloan-Kettering Cancer Center
  - New York, New York, United States, 10016
    - NYU Cancer Institute at New York University Medical Center
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104-4283
    - Abramson Cancer Center of the University of Pennsylvania
- Rhode Island
  - Providence, Rhode Island, United States, 02912
    - Brown University School of Medicine
- Wisconsin
  - Madison, Wisconsin, United States, 53792-6164
    - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
  - Milwaukee, Wisconsin, United States, 53215
    - Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Matthew R. Callstrom, MD, PhD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 1, 2008

First Submitted That Met QC Criteria