Lumbar Neoplasm, Thoracic Neoplasms
Conditions
Keywords
pain, Radiofrequency Ablation, Local Radiofrequency Ablation, Radiofrequency, Ablation, External Beam Radiation, kyphoplasty, Osteocool
Brief summary
This study looks at how well a combination of treatments helps reduce pain in people with tumors in the middle and lower back (thoracic and lumbar spine). All participants receive the same treatment, which includes a procedure to stabilize the spine (kyphoplasty), radiofrequency ablation will be with the Osteocool system and radiation therapy. The goal is to see how effective this combined approach is at relieving pain. The purpose of this study is to find out whether combining these three treatments provides better pain relief for patients with thoracic and lumbar spine tumors. This study is for adults who have cancer that has spread to the thoracic or lumbar spine and who report moderate to severe back pain (a pain score of 5 or higher on a 0-10 pain scale).
Interventions
PROCEDUREkyphoplasty with Osteocool
Participants will receive kyphoplasty with Osteocool prior to their Standard of Care External Beam Radiotherapy.
Sponsors
UNC Lineberger Comprehensive Cancer Center
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * Subjects is willing and able to comply with study procedures based on the judgement of the investigator. * Age ≥ 18 years at the time of consent. * Life expectancy beyond completion of protocol intervention of at least 1 month and deemed appropriate for treatment based on multidisciplinary review and/or investigator discretion. * Metastatic thoracic or lumbar spine tumor. Tumor should be lytic or mixed lytic/blastic. Note: there does not need to be a fracture. * Patient reported back pain of ≥ 5 on a VAS scale
Exclusion criteria
* Active infection requiring systemic therapy. * Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study). * Is currently taking Avastin or anti-coagulant meds that cannot be held. * Is currently enrolled in a cancer related clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity | Baseline and at 3 months (1 months after completion of radiotherapy) | Change in pain intensity will be measured using visual analog scale (VAS) assessments, from baseline (pre-therapy) to 1 month post completion of radiotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of thoracic and lumbar spine tumors | at 3- and 6-months following procedure | Presence of thoracic and lumbar spine residual tumors will be determined by independent radiology report (clinical assessment by a non-investigator) based on any standard of care imaging exam per treating physician's discretion. |
| Long term new or worsened vertebral body compression fracture | at 6 months following procedure | Long term new or worsened vertebral body compression fracture of thoracic and lumbar spine tumor subjects treated with kyphoplasty with osteocool ablation plus radiation therapy at the treated level will be determined by independent radiology report (clinical assessment by a non-investigator) based on any standard of care imaging exam per treating physician's discretion. |
| Retreatment of thoracic and lumbar spine tumor | at 6 months following procedure | Retreatment of thoracic and lumbar spine tumor subjects treated with kyphoplasty with Osteocool ablation plus radiation therapy is defined as treatment at the same vertebral body level with kypho- radiation therapy for disease progression within 6-months of protocol intervention collected via medical record abstraction as compared to historical control. |
| Quality of life per Patient-Reported Outcomes version of the Common Terminology Criteria | Baseline and at 6 months following procedure | Quality of life in patients with thoracic and lumbar spine tumors treated with kyphoplasty with Osteocool ablation plus radiation therapy will be evaluated using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurements prior to therapy and at completion of therapy and 6 months after procedure. PRO-CTCAE is a questionnaire that lets patients report symptoms they experience during treatment, such as pain, fatigue, nausea, or skin changes. It measures how often symptoms occur, how severe they are, and how much they interfere with daily activities. Each symptom is scored from 0 to 4 (or 0/1 for absent or present). There is currently no standard method for combining scores into a single overall score. |
| Pain level | Baseline and at 6 months following procedure | Quality of life in patients with thoracic and lumbar spine tumors treated with kyphoplasty with Osteocool ablation plus radiation will be evaluated by the Brief Pain Inventory prior to therapy and at completion of therapy and 6 months following intervention. The Brief Pain Inventory (BPI), developed by MD Anderson Cancer Center, is a patient-reported questionnaire used to measure pain severity and how pain interferes with daily activities. Patients rate their pain on a scale from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable." They also rate how much pain interferes with activities such as walking, work, mood, and sleep on a 0 to 10 scale, where 0 means "does not interfere" and 10 means "completely interferes." It is widely used in cancer patients to assess pain and its impact on quality of life. |
| Readmission rate | Up to 6 months following procedure | Quality of life in patients with thoracic and lumbar spine tumors treated with kyphoplasty with Osteocool ablation plus radiation will be evaluated by readmission rate for spine-related pain for the 6 months following the procedure via medical record abstract and self-reported care. |
| Narcotic pain medication | Up to 6 months following procedure | Narcotic pain medication in patients with thoracic and lumbar spine tumors treated with kyphoplasty with Osteocool ablation plus radiation will be evaluated by self-reported use prior to therapy and for days 1 and 7 post-kyphoplasty and Osteocool ablation and at completion of therapy and 6 months following intervention. |
| Grade 2 or higher Adverse Events | Up to 1 month | Safety of kyphoplasty with Osteocool ablation plus radiotherapy will be defined as the frequency and nature of Grade 2+ adverse events post therapy according to The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE ). NCI-CTCAE is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. AE will compared against historical controls receiving gold standard radiation therapy alone. |
Countries
United States
Contacts
CONTACTMarkeela Lipscomb
CONTACTDesma Jones
PRINCIPAL_INVESTIGATORNicole A Keefe
UNC Lineberger Comprehensive Cancer Center
Outcome results
None listed