A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy - Expansion Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Incidence of Treatment-Emergent Adverse Events in cancer patients, over the duration of a limb cryocompression cycle, as assessed by Common Terminology Criteria for Adverse Events 5.0
研究概览
简要总结
The study conducted on cancer patients is designed to test safety and efficacy of limb hypothermia in cancer patients using the new Paxman Limb Cryocompression System (PLCS). Ultimately this will lead to the development of a therapy regime that will help to prevent chemotherapy-induced neuropathy in cancer patients.
详细描述
The study will consist of 200 cancer patients, recruited from the National University Hospital, Ng Teng Fong General Hospital and Curie Oncology. Based on an established optimal temperature and pressure of limb cryocompression, cancer patients will undergo cryocompression over multiple cycles of chemotherapy to establish safety and efficacy of repeated therapy. Cryocompression of the limbs will be administered using cooling wraps attached to a cooling device. The limbs will be cooled from the digits to the elbow/knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21- 80 years.
- •Signed informed consent from patient or legal representative
- •Scheduled to receive weekly paclitaxel chemotherapy
- •Patients may receive other chemotherapy drugs alongside taxane e.g. Platinum/Herceptin.
排除标准
- •Open skin wound or ulcers of the limbs
- •History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
- •Pregnant woman
- •A score of more than 5 in Total Neuropathy Score (TNS) at baseline for cancer patients
研究组 & 干预措施
Cancer patients
Cancer patients will undergo limb cryocompression based on the established optimal temperature and pressure from previous studies over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy.
干预措施: Paxman Limb Cryocompression System (PLCS) (Device)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events in cancer patients, over the duration of a limb cryocompression cycle, as assessed by Common Terminology Criteria for Adverse Events 5.0
时间窗: 4 months
Defined as the number of patients with treatment-related intolerance as assessed by CTCAE v5.0. Grade 1-5 refer to the severity of the adverse event with higher grade indicating greater severity. Grade 3 and above will be considered severe.
Difference in qualitative symptom scores using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale
时间窗: 16 months
Difference in qualitative symptom scores using the EORTC QLQ-CIPN-20 scale before, at the end of paclitaxel chemotherapy with limb cryocompression, and at 3,6 and 12 months post-treatment. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) has 20 questions/items. This scale has a minimum of 1 and maximum of 4 for each of the 20 questions, with higher scores indicating a worse outcome.
次要结局
- PLCS usability questionnaire(4 months)