Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy - a Unicentric, Prospective-controlled, Randomized Clinical Trial for Comparison of Local Hilotherapy Vs. No Therapy to Prevent Peripheral Polyneuropathy During Taxan-based Chemotherapy Regimen
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- incidence of peripheral polyneuropathy
研究概览
简要总结
Prospective study of hilotherapy of hands and feet as prevention of chemotherapy-induced peripheral polyneuropathy induced by Taxan-based chemotherapy regimen that are used in the therapy of breast cancer and genital malignoma of the women.
详细描述
In this trial, patients receiving Taxan-based chemotherapy regimen e.g. paclitaxel, nab-paclitaxel or docetaxel in gynecological malignancies such as ovarian cnacer, breast cancer, endometrial cancer or cervical cancer will either receive cooling of hands and feet during the application of above-mentioned substances or not. The cooling will be provided by a machine called Hilotherm ChemoCare unit and will be administered constantly at a temperature of 15-17°C. Randomization will be 50:50.
if a patient is randomized in the non-interventional arm, no cooling is allowed during the application of the chemotherapy.
To assess the occurance and the extent of peripheral neuropathy, a neurological examination will take place before the start of chemotherapy, in the middle of the planned cycles of chemotherapy and after the completion of the regimen.
Quality of life and the subjective impacts of peripheral neuropathy will be evaluated via questionnaires.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Written consent for participation in this trail
- •Age ≥18 years
- •Breast or genital cancer of the woman
- •Planned application of a Taxan-based chemotherapy regimen (Paclitaxel, Nab-Paclitaxel, Docetaxel) independent of the therapy line
- •Taxan- and Platin-naivity
- •Sufficient knowledge of the German language to assure an adequat survey of patient's history
排除标准
- •pre-existing peripheral polyneuropathy
- •chemotherapy with taxan- and/or carboplatin-based regimens in a preceding therapy
- •Existence of one of the following diseases: Diabetes mellitus (of any type), neurological diseases that are involving peripheral nerve damage (e.g. Multiple Sclerosis, Amytrophic lateral sclerosis, Parkinson's disease), chronic pain syndrome, Cryoglobulinemia, cold hemagglutination, cold hives / cold contact hives, Raynaud's disease, significant peripheral artery disease,
- •Lack of knowledge of German
结局指标
主要结局
incidence of peripheral polyneuropathy
时间窗: Up to one year after the end of chemotherapy.
The primary endpoint of this study is the comparison of the incidence of a peripheral polyneuropathy (clinical Total Neuropathy Score cTNS ≥ 11) in patients with gynecologic malignoma that are undergoing Taxan-based chemotherapy regimen with or without a preventive hilotherapy of hands and feet.
次要结局
- Adverse effects of hilotherapy(Up to one year after the end of chemotherapy.)
- Tolerance of chemotherapy(From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.)
- Patient reported Quality of Life(Up to one year after the end of chemotherapy.)
- Changes in the result of electrophysical examinations(From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.)
- Residual Symptoms of Chemotherapy-induced polyneuropathy(Up to one year after the end of chemotherapy.)
- Subjective extent of CIPN(Up to one year after the end of chemotherapy.)
- Acceptance of hilotherapy(From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.)
研究者
Prof. Wolfgang Janni
Director of the Department of Gynecology and Obstetrics
University of Ulm