Long-term Evaluation of Vincristine-induced Peripheral Neuropathy in Adult Survivors of a Multicenter Prospective Cohort of Childhood and Adolescent Leukemia (LEA Cohort): a Multicenter Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 467
- 试验地点
- 1
- 主要终点
- Sensitive chemotherapy-induced peripheral neuropathy
研究概览
简要总结
Vincristine is a major anticancer agent in the management of hematological malignancies. One of the main side effects is chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a characteristic side effect of neurotoxic anticancer drugs. CIPN associated with vincristine is typically characterized by distal and symmetrical sensory symptoms (dysesthesia and paresthesia). Motor and vegetative symptoms can also be found. The prevalence of CIPN associated with vincristine during treatment ranges from 12 to 100% in children (depending on the endpoint).
The aim of this cross-sectionnal study will be to explore the CIPN prevalence and severity in adult survivors of childhood leukemia and having been treated by vincristine.
详细描述
Adult survivors of chidlhood leukemia and having been treated by vincristine will be contacted from the French childhood cancer survivor study for leukaemia (LEA Cohort) in order to seek their participation agreement.
Thereafter patients will received a self-administered questionnaire exploring the chemotherapy-induced peripheral neuropathy and related comorbidities (pain, neuropathic pain, anxiety, depression, health-related quality of life, substance use, physical activity, deprivation). Oncological and sociodemographic characteristics of participants will be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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 (> 18-year) who received a vincristine-based chemotherapy for hematological malignancy in childhood
排除标准
- •Secondary cancer (leukemia and/or cancer)
- •Active oncological pathology
- •Current cancer treatment
- •Adults protected
结局指标
主要结局
Sensitive chemotherapy-induced peripheral neuropathy
时间窗: day 1
Scores of the sensitive subscale of the QLQ-CIPN20 questionnaire (quality of life questionnaire - chemotherapy-induced peripheral neuropathy 20 questions) scores : 0 least - 100 worst
次要结局
- Anticancer drugs received(day 1)
- Anxiety severity(day 1)
- Health-related quality of life(day 1)
- Pain severity(day 1)
- Ongoing analgesic treatment(day 1)
- Hematopoietic stem cell transplant(day 1)
- Depression severity(day 1)
- Oncological characteristics(day 1)
- Motor chemotherapy-induced peripheral neuropathy(day 1)
- Neuropathic pain(day 1)
- Deprivation(day 1)
- Sociodemographic characteristics(day 1)
- Physical activity and sedentarity(day 1)
- Use of legal and illegal psychoactive drugs(day 1)
- Radiation therapy received(day 1)