Electric Stimulation Therapy, Head and Neck Neoplasm, Hyposalivation, Radiotherapy
Conditions
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.
Interventions
DEVICETENS
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.
Sponsors
Irmandade Santa Casa de Misericórdia de Porto Alegre
Federal University of Health Science of Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Flow | five minutes | Salivary flow per minute (ml) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of the Quality of Life. | 30 days | Questionarie University Washington |
Countries
Brazil
Outcome results
None listed