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HyposalivationTENS_HIRNCT03151889

Eletric Stimulation for Hipossalivation Induced by Radiotherapy

A study testing TENS in people with Hyposalivation and Electric Stimulation Therapy, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
TENS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteBrazil
Study dates
30 Aug 2017to 30 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
Show all 10Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Fabricio Edler Macagnan

    Porto Alegre, Rio Grande do Sul, 90035-070

Other trials in Brazil

About this study

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

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.

Read the 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.

Being tested
TENS
Medical subject headings
Xerostomia, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03151889
Study groupRoleWhat they receive
TENS GroupExperimentalTENS 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.
Receives: Device: TENS
Control GroupNo interventionControl Group: Pre-test evaluations (Clinic Conditions; Live Quality; Salivary Flux) and Post-test evaluations.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Salivary Flow

    Salivary flow per minute (ml)

    Measured: five minutes

Secondary outcomes (1)

  1. Impact of the Quality of Life.

    Questionarie University Washington

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2017
  2. Study start30 Aug 2017
  3. Primary completion30 Nov 2017
  4. Study completion30 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03151889
Sponsor's protocol ID
TENS-HIR 2017
Acronym
TENS_HIR
Status last verified
Aug 2020
First submitted
11 May 2017
Last updated
12 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24474477

  • 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.

    PubMed 17854932

  • 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.

    PubMed 11355268

  • 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.

    PubMed 10530742

  • 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.

    PubMed 11491236

  • 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.

    PubMed 22668705

  • 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.

    PubMed 20963353

  • 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.

    PubMed 25879367

  • 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.

    PubMed 20882668

  • 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.

    PubMed 272988

  • 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.

    PubMed 15716838

Questions about this trial

What is this clinical trial studying?

A study testing TENS in people with Hyposalivation and Electric Stimulation Therapy, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Salivary Flow (time frame: five minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03151889, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.

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