Eletric Stimulation for Hipossalivation Induced by Radiotherapy

NCT ID: NCT03151889

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-30
• Study Completion Date: 2018-12-30

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.

Conditions

Hyposalivation; Electric Stimulation Therapy; Head and Neck Neoplasm; Radiotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TENS Group

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.

Group Type: EXPERIMENTAL

TENS

Intervention Type: 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.

Control Group

Control Group: Pre-test evaluations (Clinic Conditions; Live Quality; Salivary Flux) and Post-test evaluations.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Starts radiotherapy treatment without previous hipossalivation

• 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

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Irmandade Santa Casa de Misericórdia de Porto Alegre

OTHER

Sponsor Role: collaborator

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Fabrício Edler Macagnan

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fabricio Edler Macagnan

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

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Other Identifiers

TENS-HIR 2017

Identifier Type: -

Identifier Source: org_study_id