Tracjectories and Predictors of Chemotherapy Induced Peripheral Neuropathy in Children With Acute Lymphoblastic Leukemia: A Perspective Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 173
- 试验地点
- 3
- 主要终点
- Pediatric chemotherapy-induced peripheral neuropathy (P-CIN) scale
研究概览
简要总结
The goal of this study is to explore the trajectory patterns of chemotherapy induced peripheral neuropathy over the course of chemotherapy and identify predictors of distinct trajectories in children with acute lymphoblastic leukemia. A perspective longitudinal study design is utilized. Chemotherapy induced peripheral neuropathy was assessed at one week after the first use of Vincristine (VCR) (T1), one week after the second use of VCR (T2), one week after the third use of VCR (T3), one week after the fourth use of VCR (T4), two weeks after T4 (T5), two weeks after T5 (T6), two weeks after T5 (T7). Patients' demographic and clinical characteristics, physical symptoms, nutrition status, psychological distress, sleep quality, physical activity, perceived social support and coping strategy are obtained at baseline.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with acute lymphoblastic leukemia
- •aged from 8 to 17 years
- •will receive vincristine according the Chinese Children's Cancer Group Acute Lymphoblastic Leukemia-2020 Project (CCCG-ALL-2020)
- •conscious with sufficient cognitive abilities to understand and express their physical state and psychological feelings accurately
- •written informed assent is obtained from the children and their parents for their participation in the study
排除标准
- •participating other experimental trials, such as electrical stimulation, exercise therapy may improve CIPN symptoms.
- •with severe complications, including but not limited to significant heart, brain, or lung function failure.
- •had peripheral neuropathy symptoms caused by other diseases like genetic diseases, spinal cord injury.
- •had neuromuscular diseases (e.g., traumatic brain injury and cerebral palsy).
- •had central nervous system cancer or secondary cancer.
- •had multiple treatment like radiotherapy.
结局指标
主要结局
Pediatric chemotherapy-induced peripheral neuropathy (P-CIN) scale
时间窗: One week after the first use of Vincristine (VCR) (T1), one week after the second use of VCR (T2), one week after the third use of VCR (T3), one week after the fourth use of VCR (T4), two weeks after T4(T5), two weeks after T5(T6), two weeks after T6(T7)
For measuring participants' peripheral neuropathy induced by chemotherapy. The total score ranges from 0 to 65 with higher scores indicating more severe chemotherpay induced peripheral neuropathy.
次要结局
未报告次要终点
研究者
Dr Eva Ho
Associate professor
The Hong Kong Polytechnic University