High Tone Therapy for Chemotherapy-induced Neuropathy in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Alleviation of paresthesias (VAS)
研究概览
简要总结
The HiToP ® 191 PNP an certified device licensed for the treatment of neuropathia.
The home-based treatment is to be performed only in accordance with the approved Investigational Plan (CIP) on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.
The study is multicenter, randomized, double-blind, and placebo-controlled.
Primary Objective: Comparison of the change of paresthesias from baseline until end of therapy between the two patient groups, assessed by questionnaires
Secondary Objectives: Further symptoms of neuropathy as well as on health-related quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •- Patients with histologically verified breast cancer and neoadjuvant or adjuvant treatment with a taxane derivate (e.g., Paclitaxel, Docetaxel): This group was chosen due to relatively high risk of neuropathy due to this special therapeutic agent 1,
- •Cumulative dose of at least 3 cycles
- •Interval of 2 weeks since the last chemotherapeutic cycle in order to prevent false worsenings due to delayed neurotoxic effects
- •Life expectancy of at least 3 months
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2 (that is, the capability to walk and to spend less than 50% of waking hours sitting or lying)
- •Ability to walk (with or without aids)
- •European Organisation for Research and Treatment of Cancer (EORTC) common toxicity criteria (CTC) peripheral sensory neuropathy grade 1 or 2
- •Intensity of paresthesias of > 3/10 on the Visual Analog Scale (VAS)
排除标准
- •- Prevalent neuropathy of different etiology
- •Serious central-neurological or psychiatric disorder that would interfer with a proper order of the study, according to the judgement of the investigators
- •Minors or persons unable to give informed consent
- •Current neurotoxic medication
- •Implanted pacemakers or defibrillators
- •Pregnancy
- •Wounds in the area to be treated, acute local or systemic infection
- •Peripheral arterial occlusive disease > grade 2
研究组 & 干预措施
Verum group
干预措施: HiToP 191 PNP (Device)
Placebo group
干预措施: Placebo device (Device)
结局指标
主要结局
Alleviation of paresthesias (VAS)
时间窗: baseline vs. one day after the last treatment session
Visual analog scale, 0-10, higher score = worse
次要结局
- Further neuropathic symptoms (via EORCT CIPN20 questionnaire)(baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session)
- Further neuropathic symptoms (via VAS questionnaire)(baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session)
- Quality of life (via EORCT C30 questionnaire)(baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session)