Regional Cryotherapy in Preventing Paclitaxel Induced Peripheral Neuropathy in Patients With Early and Locally Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Proportion of patients reporting level C and above subjective symptoms, in cryotherapy arm versus controlled arm, based on the Patient Neurotoxicity Questionnaire (PNQ) at 3 months after baseline
研究概览
简要总结
The trial will be preceded by a pilot phase study in 5 patients.
This will then be followed by the randomized 1:1 phase II trial testing the utility of regional cryotherapy in preventing or reducing paclitaxel-induced peripheral neuropathy compared to no treatment.
It is hypothesized that cryotherapy causes regional blood vessel constriction and decreases the paclitaxel exposure to the distal epithelial nerve fibres, thus resulting in decreased nerve damage.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent prior to any study specific procedures.
- •Age ≥ 21 years old
- •Patients with histologically confirmed early or locally advanced breast cancer
- •Must be receiving 12x weekly sessions of paclitaxel as part of their adjuvant or neo-adjuvant chemotherapy
- •Must have routine chemotherapy lab investigations as per institutional practice
- •Concurrent use of Trastuzumab and/or Pertuzumab for cerbB-2 positive patients as per institutional practice is allowed
- •Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
排除标准
- •Patients diagnosed with pre-existing or history of peripheral neuropathy (regardless of cause)
- •Patients with history of Raynaud's disease
- •Prior use of taxane-based chemotherapy
- •Concurrent use of other neuro-toxic chemotherapy with paclitaxel
- •Patients who have had any axillary clearance surgery and without a central venous access device for chemotherapy administration
- •Patients with any severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation in the clinical study.
研究组 & 干预措施
Paclitaxel and Elasto-Gel™ Cryotherapy
Cryotherapy will be applied using Elasto-Gel™ hypothermia mitts and slippers for 15 minutes before, during and 15 minutes after each paclitaxel infusion.
干预措施: Elasto-Gel™ (Device)
Paclitaxel and Elasto-Gel™ Cryotherapy
Cryotherapy will be applied using Elasto-Gel™ hypothermia mitts and slippers for 15 minutes before, during and 15 minutes after each paclitaxel infusion.
干预措施: Paclitaxel (Drug)
Paclitaxel alone
Paclitaxel will be administered without cryotherapy.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Proportion of patients reporting level C and above subjective symptoms, in cryotherapy arm versus controlled arm, based on the Patient Neurotoxicity Questionnaire (PNQ) at 3 months after baseline
时间窗: From commencement to completion of 12 paclitaxel infusions - estimated 3 months
PNQ scale ranges from scores A to E; with scoring of A being not affected neuropathy, and E with the worst neuropathy
次要结局
- Incidence of adverse events, in cryotherapy arm versus controlled arm(From commencement to completion of 12 paclitaxel infusions - estimated 3 months)
- Proportion of patients reporting level C and above subjective symptoms, in cryotherapy arm versus controlled arm, based on the Patient Neurotoxicity Questionnaire (PNQ) at 15 months after baseline(From commencement to completion of primary chemotherapy - estimated 15 months)
- Proportion of patients with lower sensory velocity and amplitudes (based on nerve conduction tests), in cryotherapy arm versus controlled arm, at 15 months after baseline(From commencement to completion of primary chemotherapy - estimated 15 months)
- Proportion of patients reported intolerance and require cessation of therapies, in cryotherapy arm versus controlled arm(From commencement to completion of 12 paclitaxel infusions - estimated 3 months)