Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 188
- 试验地点
- 3
- 主要终点
- NFL level correlation
研究概览
简要总结
Investigation of which patients treated with paclitaxel have an increased risk of developing peripheral neuropathy.
详细描述
The primary aim of this study is to validate the protein neurofilament light chain (NFL) as a biomarker of the side effect paclitaxel-induced peripheral neuropathy (PIPN) and its utility in predicting this side effect in patients with breast cancer. The investigators want to include 188 patients at four different trial sites. The patients must follow their normal treatment cycles while getting blood drawn during their treatment period however maximal 4 cycles.
Blood samples are dawn before treatment initiation and once before each new cycle start in order to measure neurofilament light chain (NFL) before and during treatment. The investigators also want to take a skin biopsy before treatment start and after either cycle 3 or 4.
The primary endpoint of the study is if serum NFL>100 pg/ml after first cycle of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Willing to give informed consent
- •Scheduled to receive neo-adjuvant or adjuvant paclitaxel treatment
- •Able to speak and understand Danish
- •Diagnosed with breast cancer
- •Paclitaxel naïve patients
排除标准
- •Neurodegenerative diseases (e.g., neuropathy from another cause, previous apoplexy, disc herniation
- •Type 1 or 2 diabetes
- •Breastfeeding
- •Relapse of cancer diagnosis
- •Diagnosed with human immunodeficiency virus (HIV)
- •Participation in other clinical trials where the dose of paclitaxel is changed, or the aim is to prevent neuropathic pain or decrease NFL level (except if the intervention is to use cooling gloves).
- •Previous treatment with neurotoxic chemotherapy
- •Chronic pain from another cause
- •Metastatic cancer
结局指标
主要结局
NFL level correlation
时间窗: Before treatment start and during four cycles (one cycle equals 3 weeks)
The primary endpoint of the study is if serum NFL\>100 pg/ml after first cycle (one cycle equals 3 weeks) of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy.
次要结局
- Genes and NFL(Before treatment start and during four cycles (one cycle equals 3 weeks))
- Genes and Paclitaxel(Before treatment start and during four cycles (one cycle equals 3 weeks))
- IENFD(Before treatment start and during four cycles (one cycle equals 3 weeks))
- Paclitaxel exposure(Before treatment start and during four cycles (one cycle equals 3 weeks))
- Skin biopsies(Before treatment start and during four cycles (one cycle equals 3 weeks))
- PHS(Before treatment start and during four cycles (one cycle equals 3 weeks))
- Genes and PIPN(Before treatment start and during four cycles (one cycle equals 3 weeks))
- Drug-drug interactions(Before treatment start and during four cycles (one cycle equals 3 weeks))
- Nerve fiber dysfunction(Before treatment start and during four cycles (one cycle equals 3 weeks))