Vulnerability and Risk of Neuropathic Pain in Cancer: Validation of a Predictive Tool to Optimize Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 625
- 试验地点
- 36
- 主要终点
- CANoPy score (Z-score)
研究概览
简要总结
Successive and repeated therapeutic interventions during cancer management - surgery, chemotherapy, radiotherapy - can all, to varying degrees, generate acute pain, central pain sensitization and chronic pain. Almost 58% of patients suffer from chronic pain, often of the neuropathic type, with altered quality of life and disease burden amplified by difficulty in achieving effective relief.
Indeed, neuropathic pain in cancer remains difficult to treat, often arrives insidiously, may persist well beyond cancer remission, and frequently has a fate that is difficult to predict. Current treatments for neuropathic pain are based on the recommendations of learned societies, but therapeutic failures are frequent, and iatrogenic pathology is high. Many factors have been identified as being associated with the development of chronic pain in cancer patients. The intensity of preoperative pain, opioid consumption, age, sleep disorders, cognitive-emotional state, psychological vulnerability and social precariousness are all factors that influence and perpetuate chronic pain linked to cancer and its management. Several studies have shown that 6 months or 1 year after cancer diagnosis, there are various pain trajectories, enabling us to identify several pain patient phenotypes. The patient's overall state of vulnerability at the time of cancer diagnosis has an impact on the trajectory of pain chronicisation, and it is often difficult for clinicians to apprehend this risk. In practice, we lack a validated, easy-to-use tool that would enable us to predict the risk of pain chronicisation for each patient, even before the start of the treatment process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Cancer patients and Healthy Volunteers
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient over 18 years of age,
- •Patient suffering from cancer (breast, gynecological, colorectal, lung) and having to undergo one or more anti-cancer therapeutic procedures (chemotherapy, surgery, hormonal therapy, radiotherapy, targeted therapy, etc.),
- •Sufficient cooperation and understanding to comply with the study requirements,
- •Agreement to give oral consent for the study,
- •Affiliation with the French Social Security system.
排除标准
- •History of cancer and anti-cancer therapy (surgery, chemotherapy, radiotherapy, hormone therapy, targeted therapy, etc.),
- •History and/or presence of primary brain tumors (glioblastoma, meningioma, neurofibroma, etc.) ),
- •History of neurological disorders (Parkinson's disease, Alzheimer's disease, dementia, epilepsy, moderate to severe head trauma, etc.),
- •Medical and/or surgical history judged by the investigator or his representative to be incompatible with the study,
- •Subject whose cooperation and understanding do not allow strict compliance with the conditions laid down in the protocol,
- •Pregnant or breast-feeding women,
- •Beneficiary of a legal protection measure.
- •Inclusion Criteria Healthy Volunteers:
- •Subject over 18 years of age,
- •Subject free of any treatment in the 7 days preceding inclusion, in particular no use of analgesics, or judged by the investigator or his representative to be compatible with the study
- •Subject with no history of cancer,
- •Subject considered to be in good health by the investigator,
- •Sufficient cooperation and understanding to comply with the study requirements,
- •Agreement to give oral consent to the study,
- •Affiliation with the French Social Security system,
- •Exclusion Criteria Healthy Volunteers:
- •Subjects with a medical and/or surgical history judged by the investigator or his representative to be incompatible with the trial,
- •Subjects whose cooperation and understanding do not allow strict compliance with the conditions laid down in the protocol,
- •Pregnant or breast-feeding woman,
- •Participating in another clinical trial, or within the exclusion period, or having received a total amount of compensation exceeding 4500 euros over the 12 months preceding the start of the trial,
- •Benefiting from a legal protection measure.
研究组 & 干预措施
Cancer patients
500 cancer patients: 100 women with breast cancer, 100 women with gynecological cancer, 150 patients with lung cancer (100 men, 50 women) and 150 patients with colorectal cancer (100 men, 50 women).
干预措施: Cognitive-emotional and pain assessments (Other)
Healthy volunteers controls
125 healthy control volunteers from the volunteer database
干预措施: Cognitive-emotional and pain assessments (Other)
结局指标
主要结局
CANoPy score (Z-score)
时间窗: 12 months
Calculation of the CANoPy score (Z-score) predictive of the development of neuropathic pain. The z-scores are then averaged across endpoints for each patient.
CANoPy score (Z-score)
时间窗: Baseline
Calculation of the CANoPy score (Z-score) predictive of the development of neuropathic pain. The z-scores are then averaged across endpoints for each patient.
CANoPy score (Z-score)
时间窗: 6 months
Calculation of the CANoPy score (Z-score) predictive of the development of neuropathic pain. The z-scores are then averaged across endpoints for each patient.
次要结局
- Assessment of cognitive status using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG) questionnaire(12 months)
- Assessment of emotional status using the Anxiety and Depression Scale (HAD)(12 months)
- Pain assessment using the Numerical Pain Scale (EN)(12 months)
- Pain assessment using the Neuropathic Pain Questionnaire (DN4)(12 months)
- Evaluation of social vulnerability using the questionnaire Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES)(12 months)
- Assessment of analgesic consumption(12 months)
- Assessment of quality of life using the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)(12 months)
- Assessment of disease perception and beliefs using the Illness Perception Questionnaire Revised (IPQ-R)(12 months)
- Assessment of quality of sleep using the Pittsburgh Sleep Quality Index (PSQI)(12 months)
- Assessment of disease perception and beliefs using the disease-specific Cancer Locus of Control Scale (CLCS)(12 months)
- Pain assessment using the Numerical Pain Scale (EN)(Baseline)
- Pain assessment using the Neuropathic Pain Questionnaire (DN4)(Baseline)
- Pain assessment using the Numerical Pain Scale (EN)(6 months)
- Pain assessment using the Neuropathic Pain Questionnaire (DN4)(6 months)
- Evaluation of social vulnerability using the questionnaire Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES)(Baseline)
- Assessment of cognitive status using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG) questionnaire(Baseline)
- Assessment of cognitive status using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG) questionnaire(6 months)
- Assessment of emotional status using the Anxiety and Depression Scale (HAD)(Baseline)
- Assessment of emotional status using the Anxiety and Depression Scale (HAD)(6 months)
- Evaluation of social vulnerability using the questionnaire Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES)(6 months)
- Assessment of analgesic consumption(Baseline)
- Assessment of quality of life using the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)(Baseline)
- Assessment of quality of sleep using the Pittsburgh Sleep Quality Index (PSQI)(Baseline)
- Assessment of quality of life using the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)(6 months)
- Assessment of quality of sleep using the Pittsburgh Sleep Quality Index (PSQI)(6 months)
- Assessment of disease perception and beliefs using the Illness Perception Questionnaire Revised (IPQ-R)(Baseline)
- Assessment of disease perception and beliefs using the disease-specific Cancer Locus of Control Scale (CLCS)(Baseline)
- Assessment of disease perception and beliefs using the Illness Perception Questionnaire Revised (IPQ-R)(6 months)
- Assessment of disease perception and beliefs using the disease-specific Cancer Locus of Control Scale (CLCS)(6 months)
- Assessment of analgesic consumption(6 months)