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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

Primary Purpose

Head and Neck Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS), Head and Neck Cancer, dry mouth

Eligibility Criteria

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

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

Sites / Locations

University of RochesterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Measure by responses to XeQoL questionnaire

Secondary Outcome Measures

Incidence of Treatment-Related Adverse Events [Safety and Tolerability]

Measured by adverse event severity and quantity

Full Information

NCT ID

NCT04805528

First Posted

March 15, 2021

Last Updated

July 11, 2023

Sponsor

University of Rochester

1. Study Identification

Unique Protocol Identification Number

NCT04805528

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 10, 2022 (Actual)

Primary Completion Date

May 31, 2025 (Anticipated)

Study Completion Date

May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

Keywords

Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS), Head and Neck Cancer, dry mouth

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) Therapy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)

Intervention Description

Twice weekly ALTENS therapy for 12 weeks

Primary Outcome Measure Information:

Title

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

Description

Measure by responses to XeQoL questionnaire

Time Frame

6 Months

Secondary Outcome Measure Information:

Title

Incidence of Treatment-Related Adverse Events [Safety and Tolerability]

Description

Measured by adverse event severity and quantity

Time Frame

6 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mary Kay Winchell

Phone

(585) 273-4839

Marykay_Winchell@URMC.Rochester.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Cummings

Phone

(585) 275-9993

Michael_Cummings@URMC.Rochester.edu

Facility Information:

Facility Name

University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Therese Smudzin

Phone

585-275-7848

Therese_Smudzin@urmc.rochester.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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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