Pain Clinical Trial
— FURTHEROfficial title:
Focused Ultrasound and RadioTHERapy for Noninvasive Palliative Pain Treatment in Patients With Bone Metastases
The FURTHER study aims to evaluate the effectiveness and cost-effectiveness of MR-HIFU (alone or in combination with EBRT) compared to EBRT alone, the standard-of-care, as a palliative treatment option to relieve CIBP. The FURTHER study consists of a multicenter, three-armed randomized controlled trial (FURTHER RCT) and a patient registry arm (FURTHER Registry), which will be performed in six hospitals in four European countries.
Status | Recruiting |
Enrollment | 216 |
Est. completion date | June 1, 2026 |
Est. primary completion date | January 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient capable of giving informed consent - Age = 18 years - Painful metastatic bone lesion (NRS > 2) - Patient-localised pain with a distinct pathological substrate on recent CT/MRI - Target lesion location is sufficiently accessible for MR-HIFU to expect clinical response, as judged by the (intervention) radiologist - Participant has a reasonable performance score (KPS = 50% or Zubrod/ECOG/WHO < 3) - Life expectancy = 3 months Exclusion Criteria: - Participant is not able to fit in the MR gantry - Need for surgery of targeted location due to (impending) pathological fracture - Unavoidable critical structures or dense tissues in target area - Contra-indications for MRI or sedation/anesthesia - Clinically relevant medical history or physical findings that could interfere with the patient's safety as judged by the treating physician - Participant enrolled in another clinical interventional study related to bone metastases treatment or pain relief treatment All patients meeting the FURTHER in- and exclusion criteria as described above will be included in this study, either in the FURTHER RCT or FUTHER Registry. The following inclusion criteria are used to decide upon the arm patients will participate in. If patients meet all of the following RCT inclusion criteria, they will be asked to participate in the FURTHER RCT. Alternatively, patients who do not meet one or more of these criteria will be asked to participate in the FURTHER Registry. - Painful bone lesion (NRS = 4) - Indication for EBRT treatment of a bone lesion - Exclusively palliative intention of EBRT treatment plan - No previous surgery on the target location - No neurological symptoms due to nerve involvement of target lesion - No (impending) pathological fracture) - EBRT replacable by MR-HIFU based on medical history or phyiscal findings judged by multidisciplinary team - Target lesion location is completely accessible for MR-HIFU |
Country | Name | City | State |
---|---|---|---|
Finland | TUCH Turku | Turku | |
Germany | University Hospital Cologne | Cologne | |
Italy | IOR | Bologna | |
Italy | CSSP | Roma | |
Netherlands | University Medical Center Utrecht | Utrecht | |
Netherlands | Isala Klinieken Zwolle | Zwolle |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht | Isala, Istituto Ortopedico Rizzoli, Turku University Hospital, Universitätsklinikum Köln, University of Bologna, University of Roma La Sapienza |
Finland, Germany, Italy, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain response - 14 days after completion of treatment | Patient reported pain response will be based on a Numeric Rating Scale (from 0 to 10 with 0 being no pain and 10 being the worst pain imaginable) and the pain severity index calculated from the Brief Pain Inventory (BPI) questionnaire [Cleeland 1994]. In addition, analgesic and anti-neuropathic drug use is recorded, and all opioid analgesics are expressed as the oral equivalent daily morphine use (OMED). The primary endpoint of the RCT will follow the International Consensus on Palliative Radiotherapy Endpoints for Future Clinical Trials in Bone metastases (Chow 2012). Patients will be categorized as responders when a complete or partial pain response is achieved. All other patients will be categorized as non-responders. | 14 days | |
Secondary | Pain response - 14 days after inclusion | Patient reported pain response will be based on a Numeric Rating Scale (from 0 to 10 with 0 being no pain and 10 being the worst pain imaginable) and the pain severity index calculated from the Brief Pain Inventory (BPI) questionnaire [Cleeland 1994]. In addition, analgesic and anti-neuropathic drug use is recorded, and all opioid analgesics are expressed as the oral equivalent daily morphine use (OMED). This endpoint will follow the International Consensus on Palliative Radiotherapy Endpoints for Future Clinical Trials in Bone metastases (Chow 2012). Patients will be categorized as responders when a complete or partial pain response is achieved. All other patients will be categorized as non-responders. | 14 days | |
Secondary | Patient reported pain scores - patient pain diary | Patient reported pain scores will be based on a Numeric Rating Scale (from 0 to 10 with 0 being no pain and 10 being the worst pain imaginable). This will be assessed using a daily patient pain diary during the first 21 days after completion of treatment. | 21 days | |
Secondary | Patient reported pain scores - BPI | Patient reported pain scores will be based on a Numeric Rating Scale (from 0 to 10 with 0 being no pain and 10 being the worst pain imaginable). This will be assessed using the Brief Pain Inventory (BPI) questionnaire at 7 time points during the total follow up of 6 months. | on baseline, at 1, 2, 4 and 6 weeks, and at 3 and 6 months | |
Secondary | Physician reported toxicity - CTCAE 5.0 | Assessed in seven telephone calls during the first six months following completion of treatment according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | at 3 days, at 1, 2, 4 and 6 weeks, and at 3 and 6 months | |
Secondary | Patient reported quality of life - EORTC BM22 | During the follow up time of 6 months, patients will receive the EORTC BM22 quality of life questionnaire at baseline, one, two, four and six weeks, and three and six months following completion of treatment. | on baseline, at 1, 2, 4 and 6 weeks, and at 3 and 6 months | |
Secondary | Patient reported quality of life - EORTC C15-PAL | During the follow up time of 6 months, patients will receive the EORTC C15-PAL quality of life questionnaire at baseline, one, two, four and six weeks, and three and six months following completion of treatment. | on baseline, at 1, 2, 4 and 6 weeks, and at 3 and 6 months | |
Secondary | Patient reported quality of life - EQ-5D-5L | During the follow up time of 6 months, patients will receive the EQ-5D-5L quality of life questionnaire at baseline, one, two, four and six weeks, and three and six months following completion of treatment. | on baseline, at 1, 2, 4 and 6 weeks, and at 3 and 6 months | |
Secondary | Patient reported quality of life - PGIC | During the follow up time of 6 months, patients will receive the Patient Global Impression of Change scale (a 7 point likert scale about overall improvement after treatment) at one, two, four and six weeks, and three and six months following completion of treatment. | at 1, 2, 4 and 6 weeks, and at 3 and 6 months | |
Secondary | Patient reported quality of life - HADS | During the follow up time of 6 months, patients will receive the Hospital Anxiety and Depression Scale (HADS) questionnaire at one, two, four and six weeks, and three and six months following completion of treatment.
Assessed among patients, patients' partners and caregivers by the Hospital Anxiety and Depression Scale (HADS) at baseline, two and four weeks, and three and six months fol-lowing completion of treatment. |
on baseline, at 1, 2, 4 and 6 weeks, and at 3 and 6 months | |
Secondary | Local tumour control | Assessed using CT and/or MRI imaging at patient discretion at three and/or six months after completion of treatment. | 3 and 6 months | |
Secondary | Cost-effectiveness of the treatment | A hypothetical diagnosis related group (DRG) will be calculated from the perspective of the statutory health insurance (SHI). | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Terminated |
NCT04356352 -
Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
|
Phase 2/Phase 3 | |
Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
Completed |
NCT04466111 -
Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
|
||
Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
Completed |
NCT05868122 -
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
|
Phase 3 | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
Enrolling by invitation |
NCT06087432 -
Is PNF Application Effective on Temporomandibular Dysfunction
|
N/A | |
Completed |
NCT05508594 -
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
|
Phase 2/Phase 3 | |
Recruiting |
NCT03646955 -
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
|
N/A | |
Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
Completed |
NCT02913027 -
Can We Improve the Comfort of Pelvic Exams?
|
N/A | |
Terminated |
NCT02181387 -
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?
|
Phase 4 | |
Recruiting |
NCT06032559 -
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
|
Phase 3 | |
Active, not recruiting |
NCT03613155 -
Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
|