search
Back to results

Eletric Stimulation for Hipossalivation Induced by Radiotherapy (TENS_HIR)

Primary Purpose

Hyposalivation, Electric Stimulation Therapy, Head and Neck Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
TENS
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyposalivation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Fabricio Edler Macagnan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TENS Group

Control Group

Arm Description

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

Outcomes

Primary Outcome Measures

Salivary Flow
Salivary flow per minute (ml)

Secondary Outcome Measures

Impact of the Quality of Life.
Questionarie University Washington

Full Information

First Posted
May 11, 2017
Last Updated
August 10, 2020
Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre
search

1. Study Identification

Unique Protocol Identification Number
NCT03151889
Brief Title
Eletric Stimulation for Hipossalivation Induced by Radiotherapy
Acronym
TENS_HIR
Official Title
Transcutaneous Electric Nerve Stimulation (TENS) Treatment for Hipossalivation Induced by Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyposalivation, Electric Stimulation Therapy, Head and Neck Neoplasm, Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TENS Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control Group: Pre-test evaluations (Clinic Conditions; Live Quality; Salivary Flux) and Post-test evaluations.
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
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 Outcome Measure Information:
Title
Salivary Flow
Description
Salivary flow per minute (ml)
Time Frame
five minutes
Secondary Outcome Measure Information:
Title
Impact of the Quality of Life.
Description
Questionarie University Washington
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Fabricio Edler Macagnan
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-070
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24474477
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.
Results Reference
result
PubMed Identifier
17854932
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. doi: 10.1016/j.radonc.2007.07.019. Epub 2007 Sep 12. No abstract available.
Results Reference
result
PubMed Identifier
11355268
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. doi: 10.1111/j.1601-0825.2000.tb00128.x.
Results Reference
result
PubMed Identifier
10530742
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. doi: 10.1016/s0385-8146(99)00026-7.
Results Reference
result
PubMed Identifier
11491236
Citation
Andrews N, Griffiths C. Dental complications of head and neck radiotherapy: Part 1. Aust Dent J. 2001 Jun;46(2):88-94. doi: 10.1111/j.1834-7819.2001.tb00562.x.
Results Reference
result
PubMed Identifier
22668705
Citation
Alajbeg I, Falcao DP, Tran SD, Martin-Granizo R, Lafaurie GI, Matranga D, Pejda S, Vuletic L, Mantilla R, Leal SC, Bezerra AC, Menard HA, Kimoto S, Pan S, Maniegas L, Krushinski CA, Melilli D, Campisi G, Paderni C, Mendoza GR, Yepes JF, Lindh L, Koray M, Mumcu G, Elad S, Zeevi I, Barrios BC, Lopez Sanchez RM, Lassauzay C, Fromentin O, Beiski BZ, Strietzel FP, Konttinen YT, Wolff A, Zunt SL. Intraoral electrostimulator for xerostomia relief: a long-term, multicenter, open-label, uncontrolled, clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Jun;113(6):773-81. doi: 10.1016/j.oooo.2012.01.012.
Results Reference
result
PubMed Identifier
20963353
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. doi: 10.1590/S1808-86942010000500021.
Results Reference
result
PubMed Identifier
25879367
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.
Results Reference
result
PubMed Identifier
20882668
Citation
Strietzel FP, Lafaurie GI, Mendoza GR, Alajbeg I, Pejda S, Vuletic L, Mantilla R, Falcao DP, Leal SC, Bezerra AC, Tran SD, Menard HA, Kimoto S, Pan S, Martin-Granizo RA, Lozano ML, Zunt SL, Krushinski CA, Melilli D, Campisi G, Paderni C, Dolce S, Yepes JF, Lindh L, Koray M, Mumcu G, Elad S, Zeevi I, Barrios BC, Lopez Sanchez RM, Beiski BZ, Wolff A, Konttinen YT. Efficacy and safety of an intraoral electrostimulation device for xerostomia relief: a multicenter, randomized trial. Arthritis Rheum. 2011 Jan;63(1):180-90. doi: 10.1002/art.27766.
Results Reference
result
PubMed Identifier
272988
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. No abstract available.
Results Reference
result
PubMed Identifier
15716838
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. doi: 10.1016/j.tripleo.2004.06.080.
Results Reference
result

Learn more about this trial

Eletric Stimulation for Hipossalivation Induced by Radiotherapy

We'll reach out to this number within 24 hrs