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临床试验/NCT03405324
NCT03405324Unknown不适用

Effect of the Transcranial Direct Current Stimulation (tDCS) of the Motor Cortex on Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients

Shereen Mamdouh2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Cumulative of nausea scoring

研究概览

简要总结

this work is looking for the effect of tDCS of the motor cortex on the chemotherapy induced nausea and vomiting in cancer breast patients

详细描述

Chemotherapy has played an important role in improving patient outcomes in oncology and is a cornerstone of therapy for most patients with cancer. Of the adverse effects, none is more feared than chemotherapy-induced nausea and vomiting (CINV).

Nausea and vomiting can adversely affect patients' quality of life and make it difficult for them to perform their activities of daily living. Uncontrolled CINV can give rise to medical complications, including poor nutrition, dehydration, electrolyte imbalances, and physical and mental deterioration.The introduction and development of antiemetic drugs have significantly improved the ability of clinicians to control CINV. The mainstays of antiemetic therapy include serotonin (5-HT3) receptor antagonists (RAs) and neurokinin 1 (NK-1) RAs. Researchers and patients are seeking additional methods of controlling CINV, such as non-drug therapies. Transcranial direct current stimulation (tDCS) is a relatively simple technique requiring only a few parts.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • breast cancer therapy receiving anthracyclin based adjuvant chemotherapy and prophylaxis against nausea and vomiting

排除标准

  • patients with intracranial metallic devices or with pacemakers or any other device.
  • patients with extensive myocardial ischemia
  • patients known to have epilepsy patients refusal.

结局指标

主要结局

Cumulative of nausea scoring

时间窗: the first 72 hours after the infusion of chemotherapy

0=None 1. Loss of appetite eout alternation in eating habits 2. Dec. oral intake eout significant wgt loss, dehydration or malnutrion 3. Iv fluids, tube feeding, TPN 4. Life threatening consequence

次要结局

  • cumalative vomiting scoring(the first 72 hours after the infusion of chemotherapy)

研究者

发起方
Shereen Mamdouh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shereen Mamdouh

Lecturer of anesthesia, ICU and pain relief

Assiut University

研究点 (2)

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