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临床试验/NCT04536207
NCT04536207Unknown不适用

Effect of Cryotherapy in Controlling Peripheral Neuropathy in Cancer Children

South Valley University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Nerve conduction studies (NCS)

研究概览

简要总结

This study aimed to assess the efficacy of cryotherapy in controlling Peripheral Neuropathy in cancer children

详细描述

Peripheral neuropathy is a serious condition characterized by symmetrical, distal damage to the peripheral nerves that may be caused by several classes of drugs, including chemotherapeutic agents. Chemotherapy-induced peripheral neuropathy (CIPN) is an adverse effect estimated to occur in up to 40% of patients undergoing chemotherapy, with its incidence increasing in patients being treated with multiple agents. Pharmacists play a pivotal role in the prevention and management of CIPN by recommending evidence-based pharmacologic and non pharmacologic strategies appropriate for the individual patient.Peripheral neuropathy (PN) is a systemic disease characterized by symmetrical, distal damage to the peripheral nerves that negatively impacts patient quality of life (QOL). Prolonged symptoms associated with PN can cause pain, interfere with functional ability (e.g., dressing, driving, house-work), and disrupt emotional health.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Single (Outcomes Assessor) Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group A (control group) and Group B (study group).

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Their age will ranging from eight to seventeen years.
  • Children participated in this study will from both sexes.
  • Children receiving chemotherapy as medical treatment protocol
  • All children have polyneuropathy caused by chemotherapy.

排除标准

  • Children with Epilepsy.
  • Children with blood clotting disorder.
  • Children have Open wounds / broken skin
  • Children with severe cardiac disease
  • Uncooperative patients.

结局指标

主要结局

Nerve conduction studies (NCS)

时间窗: nerve conduction velocity for motor common peroneal nerve at day 90

nerve conduction velocity for motor common peroneal nerve

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nehad Ahmed Youness Abo-zaid

Lecturer of physical therapy, Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, South Valley University, Qena, Egypt.

South Valley University

研究点 (2)

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