A Randomized Controlled Study of Compression Therapy of Hands and Feet for the Prevention of Taxane- or Oxaliplatin-induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 358
- 试验地点
- 1
- 主要终点
- The difference in the occurrence of sensory chemotherapy-induced peripheral neuropathy (CIPN), defined as the absolute increase from the patient's baseline score in the EORTC CIPN20 sensory PN subscale.
研究概览
简要总结
Population Cohort 1 Taxane: Breast cancer patients; (neo-)adjuvant treatment Cohort 2 Oxaliplatin: Colorectal cancer patients; (neo-)adjuvant treatment Study design Multicentre, unblinded randomised controlled study Study rationale Chemotherapy-induced peripheral neuropathy is a dose-limiting side effect during treatment and cause persistent impairment and worsening of quality of life in cancer survivors.
Compression therapy could be a plausible preventive intervention, although practice changing studies are lacking.
Aims To investigate if compression therapy of the hands and feet can reduce the prevalence of both acute and persistent CIPN symptoms caused by taxanes or oxaliplatin. Furthermore, to investigate if compression therapy impact the level of taxane or oxaliplatin dose reductions.
Endpoints Primary endpoint
- The difference in the occurrence of sensory chemotherapy-induced peripheral neuropathy (CIPN) Selected secondary endpoints
- Key secondary endpoint: Difference in relative dose intensity of taxane respectively oxaliplatin.
- The difference in the occurrence of motor and autonomic chemotherapy-induced peripheral neuropathy (CIPN).
- Difference in occurrence of persistent patient-reported CIPN symptoms 1, 3 and 5 years after start of neurotoxic chemotherapy (EORTC CIPN20)
- Health-related quality of life at baseline and after 1, 3, 5 years (EORTC QLQ C30) Exploratory endpoints
- Prevalence of autonomic neurotoxicity after neurotoxic treatment, defined as increase of prevalence from baseline to one year after treatment.
Substudy
• Development of pharmacogenetic risk prediction models of acute respectively persistent taxane induced peripheral neuropathy.
Sample size Randomisation 1:1, per site Taxane cohort 268 breast cancer patients, stratification on taxane type Oxaliplatin cohort 90 colorectal cancer patients, stratification on length of treatment Follow-up Patient-reported CIPN symptoms during treatment and at time point up to 5 years post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •o Scheduled neurotoxic treatment in any of the following settings: Taxane cohort
- •Breast cancer patients planned for either neoadjuvant or adjuvant taxane treatment Oxaliplatin cohort
- •Rectal cancer patients planned for total neoadjuvant treatment including oxaliplatin
- •Colorectal cancer patients planned for adjuvant chemotherapy including oxaliplatin, without prior neoadjuvant oxaliplatin treatment
- •Understand written and oral Swedish.
排除标准
- •Previous neurotoxic chemotherapy* treatment
- •Distant metastases
- •Any psychiatric disorder or health disorder that causes an inability to make an informed consent to participate.
- •Any manifest clinically significant peripheral neuropathy according to treating physician.
- •Current lymphoedema in limbs requiring compression therapy.
- •Ongoing pregnancy.
- •Planned taxane or oxaliplatin treatment shorter than 8 weeks or longer than 26 weeks
- •Planned compression or cryotherapy of hands and/or feet during taxane or oxaliplatin
- •Taxanes (docetaxel, paclitaxel, nabpaclitaxel), platinum components (carboplatin, oxaplatin, cisplatin), vinca-alkaloids (vincristine, vinblastine, vinorelbine, eribulin), bortezomid, thalidomide, antibody drug conjugate including vedotin or emtansine.
研究组 & 干预措施
Taxane or Oxaliplatin
Use of compression therapy class 2 (approximately 20-32 mmHg) garments on feet/lower leg and hand/lower arm
干预措施: Compression therapy (Other)
Taxane or oxaliplatin
No intervention as standard therapy
结局指标
主要结局
The difference in the occurrence of sensory chemotherapy-induced peripheral neuropathy (CIPN), defined as the absolute increase from the patient's baseline score in the EORTC CIPN20 sensory PN subscale.
时间窗: This is determined by using the patient's highest reported score from treatment start and up to 6-10 weeks after the final dose (1-24 weeks of treatment).
次要结局
- Difference in relative dose intensity of taxane respectively oxaliplatin.(From start to finish of neoadjuvant or adjuvant treatment, 1-24 weeks.)