Eletric Stimulation for Hipossalivation Induced by Radiotherapy

Radiotherapy Clinical Trial

— TENS_HIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03151889
• Other study ID #: TENS-HIR 2017
• Status: Completed
• Phase: N/A
• Start date: August 30, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: August 2020
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 30, 2018
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Electric Stimulation Therapy
• Head and Neck Neoplasm
• Head and Neck Neoplasms
• Hyposalivation
• Radiotherapy
• Xerostomia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Brazil	Fabricio Edler Macagnan	Porto Alegre	RS

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre	Irmandade Santa Casa de Misericórdia de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (11)

Alajbeg I, Falcão DP, Tran SD, Martín-Granizo R, Lafaurie GI, Matranga D, Pejda S, Vuletic L, Mantilla R, Leal SC, Bezerra AC, Ménard HA, Kimoto S, Pan S, Maniegas L, Krushinski CA, Melilli D, Campisi G, Paderni C, Mendoza GR, Yepes JF, Lindh L, Koray M, — View Citation

Almeida JP, Kowalski LP. Pilocarpine used to treat xerostomia in patients submitted to radioactive iodine therapy: a pilot study. Braz J Otorhinolaryngol. 2010 Sep-Oct;76(5):659-62. English, Portuguese. — View Citation

Andrews N, Griffiths C. Dental complications of head and neck radiotherapy: Part 1. Aust Dent J. 2001 Jun;46(2):88-94. Review. — View Citation

Dawes C, Cross HG, Baker CG, Chebib FS. The influence of gland size on the flow rate and composition of human parotid saliva. Dent J. 1978 Jan;44(1):21-5. — View Citation

Hargitai IA, Sherman RG, Strother JM. The effects of electrostimulation on parotid saliva flow: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Mar;99(3):316-20. — View Citation

Lakshman AR, Babu GS, Rao S. Evaluation of effect of transcutaneous electrical nerve stimulation on salivary flow rate in radiation induced xerostomia patients: a pilot study. J Cancer Res Ther. 2015 Jan-Mar;11(1):229-33. doi: 10.4103/0973-1482.138008. — View Citation

Langendijk JA. New developments in radiotherapy of head and neck cancer: higher precision with less patient discomfort? Radiother Oncol. 2007 Oct;85(1):1-6. Epub 2007 Sep 12. — View Citation

Longman LP, McCracken CF, Higham SM, Field EA. The clinical assessment of oral dryness is a significant predictor of salivary gland hypofunction. Oral Dis. 2000 Nov;6(6):366-70. — View Citation

Malpani BL, Jaiswar RK, Samuel AM. Noninvasive scintigraphic method to quantify unstimulated secretions from individual salivary glands. Auris Nasus Larynx. 1999 Oct;26(4):453-6. — View Citation

Santos FB, Vasconcelos-Raposo JJ, Figueiredo Mdo C. Correlation between symptoms and course duration of upper aerodigestive tract cancer at early and advanced stages. Braz J Otorhinolaryngol. 2013 Nov-Dec;79(6):673-80. doi: 10.5935/1808-8694.20130125. Eng — View Citation

Strietzel FP, Lafaurie GI, Mendoza GR, Alajbeg I, Pejda S, Vuletic L, Mantilla R, Falcão DP, Leal SC, Bezerra AC, Tran SD, Ménard HA, Kimoto S, Pan S, Martín-Granizo RA, Lozano ML, Zunt SL, Krushinski CA, Melilli D, Campisi G, Paderni C, Dolce S, Yepes JF — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary Flow	Salivary flow per minute (ml)	five minutes
Secondary	Impact of the Quality of Life.	Questionarie University Washington	30 days