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Study of Non-invasive Acupuncture-like Transcutaneous Electrical Nerve Stimulation (Altens) to Help Alleviate Xerostomia After Radiation Therapy for Cancers of the Head and Neck

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ClinicalTrials.gov Identifier: NCT04805528
Recruitment Status : Not yet recruiting
First Posted : March 18, 2021
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Michael Cummings, University of Rochester

Study Description
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Brief Summary:
The purpose of this study would like to learn if acupuncture-like electrical therapy can be used in patients with head and neck cancer who have had radiation treatment to treat dry mouth.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Radiation: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) Not Applicable

Detailed Description:
In this study the investigator would like to better understand if acupuncture-like electrical therapy can be used in patients with head and neck cancer who have had radiation treatment to treat dry mouth. Acupuncture has been shown to help some people with symptoms of dry mouth, and low-level electrical stimulation of acupuncture points has been shown to have similar results as acupuncture treatment with needles.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective Study of Non-invasive Acupuncture-like Transcutaneous Electrical Nerve Stimulation (Altens) to Help Alleviate Xerostomia After Radiation Therapy for Cancers of the Head and Neck
Estimated Study Start Date : March 1, 2022
Estimated Primary Completion Date : May 31, 2025
Estimated Study Completion Date : May 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) Therapy
Six (6) small electrodes will be placed on specific points of the body using adhesive pads. These electrodes are connected to the ALTENS device, which will send controlled, low-level electrical impulses through the skin and into the tissue underneath.
 Radiation: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)
Twice weekly ALTENS therapy for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with a mean parotid dose > 25 Gy have an improvement on the XeQoL questionnaire that is significantly different than those with a mean dose < 25 Gy [ Time Frame: 6 Months ]
    Measure by responses to XeQoL questionnaire


Secondary Outcome Measures :
  1. Incidence of Treatment-Related Adverse Events [Safety and Tolerability] [ Time Frame: 6 Months ]
    Measured by adverse event severity and quantity


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • No restrictions on gender or ethnicity
  • Ability and willingness to present for ALTENS therapy over 12 weeks
  • Previous radiation to the head and neck with a dose > 50 Gy
  • Subjective complaint of dry mouth
  • No evidence of active malignancy in the head and neck region
  • Minimum of 3 months post initial curative therapy with no evidence of active disease by standard of care surveillance scans for said disease site

Exclusion Criteria:

  • Age under 18 years of age
  • Inability to present for ALTENS therapy
  • Inability to fill out quality of life questionnaires
  • Ability and desire to receive concurrent chemoradiation therapy

  • Because ALTENs may stimulate nerves similar to those of pilocarpine, the following exclusions are noted as theoretically ALTENS could produce worse symptoms

    • Unstable Angina
    • Unstable cardiac disease with hospitalization in the last 6 months
    • Presence of a pacemaker, ICD, or other electronic implanted device that could be affected
    • Myocardial infarction in the last 6 months
    • Symptomatic arrhythmia in the last 6 months
    • Severe COPD with exacerbation causing hospitalization within the last 6 months
  • Pregnancy or the possibility of pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04805528


Contacts
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Contact: Christine Huggins 585-275-5973 Christine_Huggins@URMC.Rochester.edu
Contact: Michael Cummings (585) 275-9993 Michael_Cummings@URMC.Rochester.edu

Sponsors and Collaborators
University of Rochester
More Information
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Responsible Party: Michael Cummings, Assistant Professor - Department of Radiation Oncology (SMD), University of Rochester
ClinicalTrials.gov Identifier: NCT04805528    
Other Study ID Numbers: RHAN20083
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Cummings, University of Rochester:
Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)
Head and Neck Cancer
dry mouth
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Xerostomia
Neoplasms by Site
Neoplasms
 Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases