Exploration of Circulating microRNAs as Biomarkers of Chemo-induced Peripheral Neuropathy: a Study in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Blood concentrations of microRNAs and severity score of sensory chemotherapy-induced peripheral neuropathy
研究概览
简要总结
This study aims to find out whether certain molecules in the blood, called microRNAs, are linked to how often and how severely people develop nerve damage from chemotherapy. The investigators will look at patients receiving cancer drugs known to affect the nerves, such as paclitaxel (used for lung cancer) and oxaliplatin (used for colorectal cancer).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Patient treated for colorectal cancer and scheduled to receive oxaliplatin-based adjuvant chemotherapy for at least 6 cycles, or
- •Patient treated for lung cancer and scheduled to receive paclitaxel-based chemotherapy for at least 4 cycles.
排除标准
- •Neurodegenerative disease (e.g., Parkinson's, Alzheimer's, etc.),
- •History of stroke,
- •Pre-existing neuropathy (QLQ-CIPN20 sensory score ≥ 15/100),
- •Pain (NRS ≥ 4/10),
- •Pregnant or breastfeeding women,
- •Patients under guardianship, curatorship, deprived of liberty, or under legal protection
研究组 & 干预措施
Paclitaxel group
Patients suffering from lung cancer and treated with paclitaxel
干预措施: Assessment of blood concentrations of microRNAs (Diagnostic Test)
Paclitaxel group
Patients suffering from lung cancer and treated with paclitaxel
干预措施: Chemotherapy-induced peripheral neuropathy (CIPN) - grade (Other)
Paclitaxel group
Patients suffering from lung cancer and treated with paclitaxel
干预措施: Pain assessement (Other)
Paclitaxel group
Patients suffering from lung cancer and treated with paclitaxel
干预措施: Assessment of blood concentrations of neurofilament light chain (Diagnostic Test)
Paclitaxel group
Patients suffering from lung cancer and treated with paclitaxel
干预措施: Neuropathic pain assessment (Other)
Paclitaxel group
Patients suffering from lung cancer and treated with paclitaxel
干预措施: Chemotherapy-induced peripheral neuropathy (CIPN) - severity (Other)
Oxaliplatin group
Patients suffering from colorectal cancer and treated with oxaliplatin
干预措施: Assessment of blood concentrations of microRNAs (Diagnostic Test)
Oxaliplatin group
Patients suffering from colorectal cancer and treated with oxaliplatin
干预措施: Chemotherapy-induced peripheral neuropathy (CIPN) - grade (Other)
Oxaliplatin group
Patients suffering from colorectal cancer and treated with oxaliplatin
干预措施: Pain assessement (Other)
Oxaliplatin group
Patients suffering from colorectal cancer and treated with oxaliplatin
干预措施: Assessment of blood concentrations of neurofilament light chain (Diagnostic Test)
Oxaliplatin group
Patients suffering from colorectal cancer and treated with oxaliplatin
干预措施: Neuropathic pain assessment (Other)
Oxaliplatin group
Patients suffering from colorectal cancer and treated with oxaliplatin
干预措施: Chemotherapy-induced peripheral neuropathy (CIPN) - severity (Other)
结局指标
主要结局
Blood concentrations of microRNAs and severity score of sensory chemotherapy-induced peripheral neuropathy
时间窗: day 1, day 43, and day 155
Concentrations of microRNAs will be assessed in plasma, and severity score of sensory chemotherapy-induced peripheral neuropathy will be assessed using the QLQ-CIPN20 questionnaire.
次要结局
- Grade of sensory chemotherapy-induced peripheral neuropathy(day 1, day 43, and day 155)
- Severity score of motor chemotherapy-induced peripheral neuropathy(day 1, day 43, and day 155)
- Pain occurrence and severity(day 1, day 43, and day 155)
- Occurrence of neuropathic pain(day 1, day 43, and day 155)
- Concentrations of neurofilament light chain(day 1, day 43, and day 155)