Cryotherapy to Prevent Taxane-Induced Sensory Neuropathy of the Hands and Feet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN)
研究概览
简要总结
This clinical trial investigates the effect and tolerability of cryotherapy and to evaluate whether they can prevent or improve taxane-induced sensory peripheral neuropathy in breast cancer patients. Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Patients receiving cryotherapy during infusion of taxane therapy may have lower incidence of peripheral neuropathy, better physical function, and higher quality of life as compared to patients previously reported in literature.
详细描述
PRIMARY OBJECTIVE:
I. To investigate the efficacy and tolerability of cryotherapy (Elasto Gel frozen mittens and foot wraps) and to evaluate whether they can prevent or ameliorate taxane-induced sensory peripheral neuropathy.
OUTLINE:
Patients wear Elasto Gel Therapy Mittens and Foot Wraps on both hands and feet 15 minutes prior to each infusion, during the entire infusion, and for 15 minutes after the completion of each infusion during their three months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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 >= 18 years of age with a diagnosis of breast cancer
- •Patients receiving 12-18 weeks of chemotherapy with a taxane-based regimen (4 cycles of weekly x 3 paclitaxel or 4-6 cycles of docetaxel every 3 weeks)
- •Absence of sensory peripheral neuropathy, skin or nail disorders at the start of treatment
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Ability to complete questionnaires by themselves or with assistance
- •Ability to give signed informed consent
排除标准
- •History of prior sensory/motor peripheral neuropathy from any cause
- •History of prior Raynaud's phenomenon
- •History of cryoglobulinemia
- •Active peripheral vascular disease
- •Cold intolerance
- •Prior exposure to neurotoxic chemotherapy in the last 10 years
- •Hand-foot syndrome
- •Tumor metastasis in bone, soft tissue, or skin of the hands or feet
- •Absence of one or more fingers or toes
- •Prior exposure to taxane chemotherapy
结局指标
主要结局
Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN)
时间窗: During chemotherapy (baseline), after chemotherapy (1 week post baseline), at 3 month follow up
Number of subjects to experience chemotherapy induced peripheral neuropathy (CIPN).
Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN)
时间窗: During chemotherapy (baseline), after chemotherapy (1 week post baseline), at 3 month follow up
Number of subjects to experience chemotherapy induced peripheral neuropathy (CIPN).
次要结局
未报告次要终点