Clinical trial NCT03738670: Bipolar RFA of Painful Extra-spinal Bone Metastases
Official title: Pain Evaluation After Treatment of Extra-spinal Bone Metastases With OsteoCOOL Radiofrequency (RF) Ablation System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multi-metastatic Cancer
Keywords: Pain
Extra-spinal
RFA
Radiofrequency ablation
Bone metastases
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1 month
Secondary outcomes:
measure: 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
timeFrame: 6 months
measure: Safety will be assessed according to SIR(11) / CTCAE classification
timeFrame: 6 months
measure: Mean scores variation of the morphine milligram equivalents (MME) (based on patient consumption diary) between the baseline and 6-month follow-up.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital, Strasbourg, france
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Luigi Roberto CAZZATO, MD
role: PRINCIPAL_INVESTIGATOR
References: