NCT03151889

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

August 30, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

May 11, 2017

Last Update Submit

August 10, 2020

Conditions

HyposalivationElectric Stimulation TherapyHead and Neck NeoplasmRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • Salivary Flow

    Salivary flow per minute (ml)

    five minutes

Secondary Outcomes (1)

  • Impact of the Quality of Life.

    30 days

Study Arms (2)

TENS Group

EXPERIMENTAL

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.

Device: TENS

Control Group

NO INTERVENTION

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

Interventions

TENSDEVICE

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.

TENS Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fabricio Edler Macagnan

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

Location

Related Publications (11)

  • 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.

    PMID: 24474477RESULT

  • 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.

    PMID: 17854932RESULT

  • 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.

    PMID: 11355268RESULT

  • 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.

    PMID: 10530742RESULT

  • 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.

    PMID: 11491236RESULT

  • 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.

    PMID: 22668705RESULT

  • 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.

    PMID: 20963353RESULT

  • 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.

    PMID: 25879367RESULT

  • 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.

    PMID: 20882668RESULT

  • 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.

    PMID: 272988RESULT

  • 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.

    PMID: 15716838RESULT

MeSH Terms

Conditions

XerostomiaHead and Neck Neoplasms

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic DiseasesNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 12, 2017

Study Start

August 30, 2017

Primary Completion

November 30, 2017

Study Completion

December 30, 2018

Last Updated

August 12, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)