Eletric Stimulation for Hipossalivation Induced by Radiotherapy

Not Applicable

Completed

• Conditions: Hyposalivation; Head and Neck Neoplasm; Radiotherapy; Electric Stimulation Therapy
• Interventions: Device: TENS

• Registration Number: NCT03151889
• Lead Sponsor: Federal University of Health Science of Porto Alegre

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-12
• Study Start: 2017-08-30
• Primary Completion: 2017-11-30
• Study Completion: 2018-12-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

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;

Exclusion Criteria

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TENS Group	TENS	TENS Group: Pre-test evaluations (Clinic Conditions; Live Quality; Salivary Flux); TENS treatments (50Hz / pulse duration of 250 ms / high intensities tolerated / continuously for 20 minutes / 2 sessions a week / 4 weeks / total of the 8 TENS sessions) and Post-test evaluations.

Primary Outcome Measures

Name	Time	Method
Salivary Flow	five minutes	Salivary flow per minute (ml)

Secondary Outcome Measures

Name	Time	Method
Impact of the Quality of Life.	30 days	Questionarie University Washington

Trial Locations

Locations (1)

Fabricio Edler Macagnan; 🇧🇷 Porto Alegre, RS, Brazil