Evaluation of the Efficacy of Interventional Radiology in the Management of Pain in Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 125
- 主要终点
- Difference in pain intensity measured on a numerical scale before the interventional radiology procedure, and at 7 days, 1 month, and 3 months afterward.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patient with cancer in remission;
- •Patient with cured cancer;
- •Patient under routine follow-up.
研究组 & 干预措施
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))
干预措施: Self-reported questionnaires (Other)
结局指标
主要结局
Difference in pain intensity measured on a numerical scale before the interventional radiology procedure, and at 7 days, 1 month, and 3 months afterward.
时间窗: 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.
次要结局
未报告次要终点
