Chemotherapy Induced Peripheral Neuropathy (CIPN) in Lymphoma : Longitudinal Follow up and Prognostic Factors.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Nerve conduction parameters
研究概览
简要总结
Vincristine-induced peripheral neuropathy, which is commonly a sensorimotor neuropathy, remains a major complication of lymphoma patients treated with R-CHOP. The investigators propose a clinical, electrophysiological and biological follow up of patients treated by vincristine for lymphoma to determine the factors implied in VIPN occurrence.
详细描述
Patients with lymphoma will be evaluated before chemotherapy (T1), after 4 cycles (T2), at the end of the chemotherapy treatment (If more than 4 cycles) (T3) and 6 month after the end of chemotherapy (T4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Diagnosis of indolent or aggressive B/T NHL confirmed by biopsy and requiring chemotherapy after PCR decision including vincristine, RCHOP/CHOP protocol or CHOEP
- •Accept to participate in the study
- •Age > 18 year
- •Able and willing to provide informed consent
- •Affiliated to a social security system
排除标准
- •Life-threatening emergency requiring chemotherapy in extreme urgency
- •Neuro-meningeal damage at diagnosis
- •Protected person (under guardianship or curators)
- •Person under court protection
- •Pregnant or breastfeeding woman
- •Persons deprived of liberty by judicial or administrative decision
- •Persons under forced psychiatric care
- •Persons admitted to a health or social institution for purposes other than research
- •Persons unable to express their consent
结局指标
主要结局
Nerve conduction parameters
时间窗: 6 months after the end of all the cures
Nerve conduction study (NCS) with standard NCS of the tibial and peroneal motor, sural, sural dorsal, superficial peroneal, median, ulnar, and radial sensory nerves. ENMG study will be bilateral at lower limb and only left side at upper limb. T-Reflex and F-waves will be used to assess proximal nerve function.
次要结局
- Sudoscan (dysautonomic function)(Before Chemotherapy first cure)
- Vincristin dosage(1/4 hour after ending of each infusion)
- Gait parameters using FeetMe device(Before Chemotherapy (T1))
- Biological dosages(Before Chemotherapy (T1))
- Longitudinal study of the evolution of markers of neuropathy(Before Chemotherapy first cure)