Nurse-initiated Cryotherapy Intervention for Docetaxel-induced Nail Toxicities: Case-control Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Differences in the incidence and severity of nail and skin toxicities between protected and unprotected hands
研究概览
简要总结
Between 30% and 88% of chemotherapy patients receiving docetaxel experience side effects of the hand ranging from skin and nail disfigurement, blistering, desquamation, pain, infection, and impaired treatment-related quality of life and function. Preliminary data indicate that nurse-initiated cryotherapy during treatment may lower the incidence and severity of these side effects, but several issues should be addressed before this intervention is implemented in hospital settings. These include more rigorous study design, larger sampling frames, and consideration of infection control concerns. This study will address these issues, thereby rigorously evaluating the safety and efficacy of nurse-initiated cryotherapy at Princess Alexandra Hospital.
详细描述
Research problem:
Internationally, cryotherapy for docetaxel-induced nail and skin toxicities of the hand has become a popular primary treatment. Yet there is little evidence beyond one Phase II, non-randomised, (n=45) study to support such widespread use. There are also unanswered concerns relating to the potential of this treatment to cross-infect patients at risk of immunocompromise. This phase II case-control study extends previous work to address sample size concerns, enhance methodological rigour and add new evidence with respect to infection control, prior to its possible implementation at Princess Alexandra Hospital (PAH).
Hypothesis/questions/outcomes:
Aim: This study will investigate the utility, efficacy and safety of cryotherapy, in the form of frozen gel gloves, with respect to the prevention of docetaxel-induced nail and skin toxicities in cancer patients.
Hypotheses:
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
- Single (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 receiving docetaxel as mono- or combination therapy
- •patients with no nail disorders at the start of treatment
- •life expectancy of at least 3 months
排除标准
- •patients previously treated with taxane chemotherapy
- •Raynaud's phenomenon
- •distal metastases
- •ungual pathology
- •arteriopathy
- •cold intolerance
- •peripheral neuropathy of grade 2 or higher
- •patients currently enrolled in clinical trials
结局指标
主要结局
Differences in the incidence and severity of nail and skin toxicities between protected and unprotected hands
时间窗: 12 months
次要结局
- Safety and tolerability of frozen glove treatment(12 months)
- Adequacy of infection control measure added to glove protocol(12 months)
研究者
Alexandra McCarthy
Associate Professor
Princess Alexandra Hospital, Brisbane, Australia