- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07529314
Evaluating Interventional Radiology for Cancer Pain Management (RI-LieF)
Evaluation of the Efficacy of Interventional Radiology in the Management of Pain in Patients With Cancer
Each year, the number of new cancer cases increases globally and the associated pain remains a major concern. The scientific literature shows that the prevalence and severity of cancer-related pain have decreased thanks to new therapeutic strategies and the efficacy of innovative treatments. Nevertheless, recent studies indicate that the prevalence of pain in patients with locally advanced or metastatic cancer remains high.
Cancer-related pain presents various characteristics, both in terms of timing (inflammatory and mechanical) and types (nociceptive, neuropathic, mixed, or visceral). This diversity in presentation and pathophysiology makes the condition complex, both in terms of symptom assessment and therapeutic management, requiring a multidisciplinary and often multimodal approach.
In addition to pharmacological approaches, several non-pharmacological techniques are used for this purpose, as the interventional radiology (IR), so-called minimally invasive technique. The role of IR is becoming increasingly important in pain management, particularly in the context of a growing number of cancer survivors, improved survival in the metastatic setting and the limited effectiveness of opioids. These techniques include neurolysis, embolization, consolidation techniques, ablation, and percutaneous cervical cordotomy.
The objective of the RI-Lief study is to evaluate the impact of interventional radiology on improving the quality of life of patients with locally advanced or metastatic cancer.
As part of the study, interventional radiology will be included in the standard patient care. The only additional procedure introduced by the research is the administration of questionnaires.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Guillaume ECONOMOS
- Phone Number: 04.78.86.10.99
- Email: guillaume.economos@chu-lyon.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patient (age > 18 years);
- Patient with locally advanced or metastatic cancer undergoing active management, including palliative care;
- Patient with a clinically estimated life expectancy of at least 3 months;
- Patient receiving treatment with chemotherapy, immunotherapy, targeted therapy, hormone therapy, or any other type of treatment for locally advanced or metastatic cancer;
- Patient undergoing an interventional radiology procedure for pain relief (including cases where pain relief is not the primary objective);
- Patient able to complete the proposed questionnaires.
Exclusion Criteria:
- Patient with cancer in remission;
- Patient with cured cancer;
- Patient under routine follow-up.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Self-reported questionnaires
Self-reported questionnaires will be used to assess the patient's pain (using a Numerical Rating Scale and Neuropathic Pain Symptom Inventory), satisfaction with pain management (Pain Treatment Satisfactory Scale) and the global quality of life : EORTC QLQ-C30 questionnaire ( (European Organisation for Research and Treatment of Cancer (EORTC); Quality of Life Questionnaire (QLQ) Core30 (C30))
|
Self-reported questionnaires will be used to assess the patient's pain (using a Numerical Rating Scale and Neuropathic Pain Symptom Inventory), satisfaction with pain management (Pain Treatment Satisfactory Scale) and the global quality of life (EORTC QLQ-C30 questionnaire)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in pain intensity measured on a numerical scale before the interventional radiology procedure, and at 7 days, 1 month, and 3 months afterward.
Time Frame: Baseline, 7 days, 1 month and 3 months after the radiology intervention.
|
To evaluate the efficacy of interventional radiology for pain relief in improving pain intensity in patients with locally advanced or metastatic cancer.
|
Baseline, 7 days, 1 month and 3 months after the radiology intervention.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL25_1073
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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