NCT03151889: TENS_HIR

Eletric Stimulation for Hipossalivation Induced by Radiotherapy

Completed NA Last updated 12 August 2020

What this trial tests

NA trial testing TENS in Hyposalivation in 67 participants. Completed in 30 December 2018.

Timeline

30 August 2017

Primary endpoint
30 November 2017

30 December 2018

Quick facts

Lead sponsor	Federal University of Health Science of Porto Alegre
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	67
Start date	30 August 2017
Primary completion	30 November 2017
Estimated completion	30 December 2018
Sites	1 location across Brazil

Drugs / interventions tested

• TENS

Conditions studied

• Hyposalivation — all drugs for Hyposalivation →
• Electric Stimulation Therapy — all drugs for Electric Stimulation Therapy →
• Head and Neck Neoplasm — all drugs for Head and Neck Neoplasm →
• Radiotherapy — all drugs for Radiotherapy →

Sponsor

Federal University of Health Science of Porto Alegre

Who can join

Adults 18 to 80, any sex, with Hyposalivation or Electric Stimulation Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.