Multi-metastatic Cancer
Conditions
Keywords
Pain, Extra-spinal, RFA, Radiofrequency ablation, Bone metastases
Brief summary
To evaluate the worst pain of cancer patients with painful extra-spinal bone metastases 1 month after bipolar radiofrequency ablation (RFA) performed with the Osteocool system.
Interventions
PROCEDUREPercutaneous RFA
Single session percutaneous extra-spinal bone metastasis destruction to achieve pain relief
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\) Multi-metastatic cancer patients with at least one painful lytic bone metastasis * 2\) Target lesion should correspond to a specific radiologic finding * 3\) At least a moderate pain produce by target lesion (4 on a scale of 0 to 10 over the prior 24 hours with or without pain killers intake) assessed during selection evaluation * 4\) Patients 18 years old * 5\) Able to give written consent * 6\) Life expectancy 1 months * 7\) Patient affiliated to the National Health Insurance system
Exclusion criteria
1. Radiation therapy on the target tumor terminated \< 3 weeks before treatment 2. Any contra-indication for the procedure as stated by the radiologist in terms of tumor size, proximity to neural/vascular structures making the procedure at unacceptable risk 3. Any contra-indication for the procedure as stated by the radiologist related to patient's condition (e.g. cardiac pacemakers) making the procedure at unacceptable risk 4. Impaired haemostasis 5. Concurrent participation in other experimental studies that could affect endpoints of this study 6. Contraindication to any form of sedation/anaesthesia 7. Signs of local/systemic infection identified before procedure, in accordance with standard care 8. Sclerotic metastases 9. Adults under guardianship 10. Patients under judicial protection 11. Pregnant or breastfeeding woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of responding patients reporting an improvement of at least 3 points on item 3 the worst pain in the last 24 hours of Brief Pain Inventory (BPI) questionnaire | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the mean scores of the items 3, 5, 9B and 8 of the BPI questionnaire between the baseline and 6-month follow-up | 6 months |
| Safety will be assessed according to SIR(11) / CTCAE classification | 6 months |
| Mean scores variation of the morphine milligram equivalents (MME) (based on patient consumption diary) between the baseline and 6-month follow-up. | 6 months |
| Percentage of responding patients defined by an improvement of at least 3 points on item 3 the worst pain in the last 24 hours of Brief Pain Inventory (BPI) questionnaire at 3 and 6 month follow-up. | 6 months |
Countries
France
Outcome results
None listed