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临床试验/NCT03151889
NCT03151889已完成不适用

Transcutaneous Electric Nerve Stimulation (TENS) Treatment for Hipossalivation Induced by Radiotherapy

Federal University of Health Science of Porto Alegre2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2017年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
67
试验地点
2
主要终点
Salivary Flow

研究概览

简要总结

Currently, cancer is a disease of high incidence, already considered a public health problem. Among the most prevalent are head and neck neoplasms, and depending on the location and extent of the lesion, the treatments are surgery, chemotherapy and / or radiotherapy that have a great impact on the quality of life. Radiation therapy is a frequently chosen treatment, and depending on the dose of radiation, causes changes such as hyposalivation. There are techniques for salivary flow stimulation, however, most of the options involve the use of medications, which limits administration to part of the patients. Transcutaneous electric nerve stimulation (TENS) is an alternative that has been used to stimulate salivary flow, however there is a limited number of studies that have tested this technique after radiotherapy. The aim of this study was to verify the effect of TENS in increasing the salivary flow of individuals receiving radiotherapy to treat tumors of the head and neck. The sample will have 80 patients randomly divided into two groups: TENS group and Control group. In both groups, a quality of life questionnaire (UW-QOL) will be applied and a speech-language assessment will be performed. The hypothesis of this research is that TENS is effective in increasing the amount of saliva. Secondary outcomes involve the evaluation of the effect of this technique on the quality of life, mainly in the questions: speech, chewing, saliva and deglutition.

详细描述

The sample will have 80 patients randomly divided into two groups: 1) TENS group; 2) control group. A quality of life questionnaire (UW-QOL) will be applied and a speech-language assessment will be performed. The hypothesis of this research is that TENS increasing the amount of saliva. Secondary outcomes involve the evaluation of the effect of this technique on the quality of life, mainly in the questions: speech, chewing, saliva and deglutition.

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Starts radiotherapy treatment without previous hipossalivation
  • The inclusion criteria according to information contained in electronic medical records and referred by the participants are:
  • Patients undergoing oncological follow-up for the treatment of head and neck cancer at Santa Rita Hospital through radiotherapy;
  • Have completed radiotherapy for at least 90 days;
  • Do not present a history of carcinogenic lesion in the salivary glands (sublingual, submandibular and parotid);
  • Do not present oral history of oral cancer;
  • Have not undergone cervical emptying level I;

排除标准

  • Intolerance to the TENS
  • The exclusion criteria are:
  • No xerostomia;
  • Severe dysphagia;
  • Stimulated salivary flow volume greater than 1.5 ml / minute;
  • Use of glandular protective substances or salivary stimulants during the period of data collection;
  • Use of a pacemaker or any other device that prevents electrical stimulation;
  • Being pregnant;
  • Unavailability of time to participate in the study (2x / week for one month);
  • Excessive absences during treatment (> 30% of total sessions).

结局指标

主要结局

Salivary Flow

时间窗: five minutes

Salivary flow per minute (ml)

次要结局

  • Impact of the Quality of Life.(30 days)

研究者

发起方
Federal University of Health Science of Porto Alegre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fabrício Edler Macagnan

PhD

Federal University of Health Science of Porto Alegre

研究点 (2)

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