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NCT Number: NCT03151889

Eletric Stimulation for Hipossalivation Induced by Radiotherapy

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.

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Key information

Conditions

Hyposalivation Electric Stimulation Therapy Head and Neck Neoplasm Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Radiotherapy Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fabricio Edler Macagnan

Porto Alegre, Rio Grande do Sul, 90035-070, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

TENS

Device

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 outcomes

  1. Salivary Flow

    Time frame: five minutes

    Salivary flow per minute (ml)

Secondary outcomes

  1. Impact of the Quality of Life.

    Time frame: 30 days

    Questionarie University Washington

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Collaborators

  • Irmandade Santa Casa de Misericórdia de Porto Alegre

Registry information

Official study title

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

Acronym: TENS_HIR

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 12, 2017
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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