CROPSI Study A Randomized, Observer-blinded Clinical Trial Evaluating Effectiveness of Cryotherapy vs. Cryocompression for Preventing CIPN in Women Undergoing Chemotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 196
- 试验地点
- 2
- 主要终点
- NCV (nerve conduction velocity)
研究概览
简要总结
This study's aim is to show a benefit of Cryocompression (cooling hands with additional compression of the hands) in comparison to Cryotherapy (just cooling hands) in female cancer patients (with gynecological cancer) receiving chemotherapy with taxanes.
Patients who are not eligible for either cryocompression or cryotherapy are included in a control group.
The expected benefits with additional compression to the cryotherapy are reduction of chemotherapy induced polyneuropathy and reduced nail changes.
详细描述
In this randomized, observer blinded, monocentric study 196 patients will be included in a four years period.
The patients will be 1 to 1 randomized in either cryocompression or cryotherapy. Patients who are not eligible for either cryocompression or cryotherapy will be included in the control group.
Additionally every patient (excluding the control group) receives cryotherapy for the feet.
Before receiving the first chemotherapy CTCAE, Semmes-Weinstein monofilament examination (SWME), vibration test for hand and feet, and nerve conduction velocity (NCV) only for hands.
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
盲法说明
It is an observer blinded study.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with breast cancer or other gynecological tumors
- •planned neoadjuvant, adjuvant or palliative chemotherapy
- •</= two lines chemotherapy as pre-therapy (adjuvant chemotherapy counts as one line)
- •at least three cycles of chemotherapy with taxanes
- •written consent
- •18 years and older
排除标准
- •PNP >/= 2
- •neuralgia
- •metastases in bones, metastases in soft tissue (located in skin, hands or feet)
- •Raynaud syndrome
- •peripheral arterial ischemia
- •hand-feet syndrome
结局指标
主要结局
NCV (nerve conduction velocity)
时间窗: 4 years
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
CTCAE 4.03
时间窗: 4 years
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
SWME (Semmes Weinstein monofilament examination)
时间窗: 4 years
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
tuning-fork-test
时间窗: 4 years
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
EORTC QoLCIPN20
时间窗: 4 years
Patient-reported outcomes (PRO)
Neuro-QoL Domain for Upper Extremity (FineMotor, ADL)
时间窗: 4 years
Patient-reported outcomes (PRO)
次要结局
- National Cancer Institute Common Toxicity Criteria version 2(4 years)
- time frame until polyneuopathy occurs(4 years)