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临床试验/CTRI/2018/06/014578
CTRI/2018/06/014578尚未招募2 期

"A Randomized Control Trial to study the effect of indigenous Cryotherapy on prevention of Chemotherapy Induced Peripheral Neuropathy (CIPN) in cancer patients receiving neurotoxic drugs attending Chemotherapy units, PGIMER, Chandigarh (2018-19)â€

C Sam Ila Kyndiah2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年2月7日最近更新:
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适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
2
主要终点
Chemotherapy Induced Peripheral Outcome (CIPN) measured by NCI CTCAE criteria
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study objectives are:

  1. To develop a protocol for application of Indigenous Cryotherapy
  2. To ascertain the effect of Cryotherapy on prevention of Chemotherapy Induced Peripheral Neuropathy (CIPN) in patients receiving neurotoxic chemotherapy drugs as compared to routine therapy.

Hypothesis

H0:  There is no effect of indigenous cryotherapy on prevention of chemotherapy induced peripheral neuropathy as compared to routine therapy

HA : There is an effect of  indigenous cryotherapy on prevention  of chemo induced peripheral neuropathy as compared to routine therapy.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)（—）
性别
All

入选标准

  • •1.Patients suffering from cancer undergoing chemotherapy for the first time with neuro-toxic drugs.
  • •2.Patients willing to participate.

排除标准

  • •1.Known case of Peripheral neuropathy(Diabetic neuropathy, Raynaud’s syndrome, carpal tunnel syndrome) 2.Patients who are unable to report paraesthesia and pain 3.Patient Ë‚18 years.

结局指标

主要结局

Chemotherapy Induced Peripheral Outcome (CIPN) measured by NCI CTCAE criteria

时间窗: 2

次要结局

  • Improved ADLs(6)

研究者

发起方
C Sam Ila Kyndiah
申办方类型
Other [self]

研究点 (2)

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