A Feasibility Study Investigating Chemotherapy-induced Neuropathy Using Multi-frequency Tactilometry and Patient-reported Outcomes (PRO)
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Difference in VPT from baseline to 6 mo.
研究概览
简要总结
Chemotherapy induced peripheral neuropathy (CIPN) is among the most feared side effects to cancer treatment. The development of CIPN can lead to discontinuation or omission of antineoplastic drugs, possibly affecting efficacy of cancer treatment. There is a lack of knowledge about the natural course of CIPN and to this date, there are no available methods for the early detection of CIPN. With no effective prevention or treatment options, the condition has severe impact on patient quality of life and healthcare expenditure.
This study will investigate the natural course of paclitaxel- and oxaliplatin induced peripheral neuropathy using novel diagnostic techniques. Multi-frequency vibrational technology has provided an objective method for the early detection of diabetic neuropathy. Our study will test the feasibility of this method within the field of clinical oncology and CIPN.
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
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •A diagnosis of cancer.
- •Fulfil the criteria for starting chemotherapy.
- •Scheduled to undergo at least 4 courses of paclitaxel- or oxaliplatin-based chemotherapy.
- •No prior paclitaxel, oxaliplatin or other neurotoxic chemotherapy.
排除标准
- •Unable to complete PRO measures.
- •Previous neurotoxic chemotherapy.
结局指标
主要结局
Difference in VPT from baseline to 6 mo.
时间窗: through study completion, an average of 1 year and 6 months
For patients receiving paclitaxel: Difference in vibrograms from baseline compared to vibrograms after the end of the 6th course of chemotherapy or the last course of chemotherapy (if before course no. 6).
Difference in VPT from Baseline to 4 mo.
时间窗: through study completion, an average of 1 year and 6 months
For patients receiving oxaliplatin: Difference in vibrograms from baseline compared to vibrograms after the end of the 4th course of chemotherapy or the last course of chemotherapy (if before course no. 4).
次要结局
- Difference in PRO from baseline and during 1. course chemotherapy.(up to 5 days)
- Difference in VPT from baseline to af chemotherapy course no. 3(through study completion, an average of 1 year and 6 months)
- Difference in VPT from baseline to af chemotherapy course no. 2(through study completion, an average of 1 year and 6 months)
- No. of dose reductions(through study completion, an average of 1 year and 6 months)
- Difference in VPT from baseline and during 1. course chemotherapy(up to 5 days)
- Difference in PRO from baseline to after chemotherapy course no. 2(through study completion, an average of 1 year and 6 months)
- Difference in PRO from baseline to after chemotherapy course no. 3(through study completion, an average of 1 year and 6 months)
- No. of discontinuations(through study completion, an average of 1 year and 6 months)