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

Sponsor

University of Rochester (Other)

Overall Status

Recruiting

CT.gov ID

NCT04805528

Collaborator

(none)

Enrollment

Location

Arm

38.7

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Radiation: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)	N/A

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

Study Type:

Interventional

Anticipated 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

Actual Study Start Date :

Mar 10, 2022

Anticipated Primary Completion Date :

May 31, 2025

Anticipated Study Completion Date :

May 31, 2025

Arms and Interventions

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

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

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 [6 Months]
Measure by responses to XeQoL questionnaire

Secondary Outcome Measures

Incidence of Treatment-Related Adverse Events [Safety and Tolerability] [6 Months]
Measured by adverse event severity and quantity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

University of Rochester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Mar 18, 2021

Last Update Posted:

Jun 9, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Michael Cummings, Assistant Professor - Department of Radiation Oncology (SMD), University of Rochester

Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)

Head and Neck Cancer

dry mouth

Additional relevant MeSH terms:

Head and Neck Neoplasms

Xerostomia

Study Results

No Results Posted as of Jun 9, 2022