Assessment of effectiveness of limb cooling in prevention of Taxane-induced peripheral neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- To study difference in development of moderate to severe TIPN of CTCAE gd greater than and equal to 2 in the control and intervention arms
研究概览
简要总结
CIPN is a significant and sometimes dose-limiting side effect for patients receiving certain chemotherapy agents like Platinums, Taxanes, Vinca alkaloids certain ADCs like Polatuzumab vedotin, Enfortumab vedotin. The prevalence of CIPN varies across the literature from 30-90 percent depending on the chemotherapy agent, total dose and comorbidities predisposing to neuropathies. The neurotoxic effects may persist for years in a proportion of patients, varying from 10-40 percent of those who develop CIPN. This compromises quality of life and productivity for those with prolonged remissions or who are cured of malignancy.
There are presently no drugs (with strong recommendation) for the treatment of CIPN once it develops. It is mostly managed with drug dose modification or omission. Hence, the focus has shifted to prevention of CIPN using various drugs including antidepressants, anti-epileptics, anti-oxidants, vitamins, use of physical therapies including acupuncture.
Use of cryotherapy has shown promise with conflicting evidence in reducing rates of higher grade CIPN in some research studies. These studies have primarily studied the use of cryotherapy in the prevention of TIPN, with small sample size in Japanese and Caucassian populations. There are currently no prospective randomised control trials showing the efficacy of cryotherapy in the prevention of CIPN or TIPN in the Indian population.
We wish to study the efficacy of cryotherapy in the prevention of moderate to severe CIPN (CTCAE gd greater than and equal to 2) in Indian patients receiving taxane based chemotherapy (paclitaxel or nab-paclitaxel) either alone or in combination with other non-neurotoxic agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than and equal to 18yrs and less than 70yrs
- •ECOG PS less than equal to 2
- •Cancer patients planned for Taxane based chemotherapy.
- •A signed declaration of consent.
排除标准
- •Prior chemotherapy exposure
- •History or clinical exam suggestive of Raynaud’s phenomenon, cold intolerance, frost bite, peripheral vascular disease.
- •Prior known neuropathy of any etiology (including but not limited to alcohol, diabetic, nutritional, connective tissue disease, porphyria, critical illness, infectious, vasculitic, compression.
- •Organ dysfunction (renal/cardiac/liver) precluding use of chemotherapy drugs under study.
结局指标
主要结局
To study difference in development of moderate to severe TIPN of CTCAE gd greater than and equal to 2 in the control and intervention arms
时间窗: At start (baseline) and 12 weeks after initiation of study chemotherapy agents
次要结局
- To assess change in EORTC QLQ-CIPN20 scores in control and study arm.(At baseline and at end of 12 weeks)
- To assess need for omission or dose reduction in the chemotherapy protocol(At start of each chemotherapy cycle)
- To compare nerve conduction study parameters in study and control arm(At baseline and 12 weeks after the start of the study chemotherapy agents)
研究者
Naveen Yadav
PGIMER