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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04805528
• Other study ID #: RHAN20083
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: July 2023
• Source: University of Rochester
• Contact: Mary Kay Winchell
• Phone: (585) 273-4839
• Email: Marykay_Winchell[@]URMC.Rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Xerostomia

Intervention

Radiation:
• Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)
Twice weekly ALTENS therapy for 12 weeks

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 Months
Secondary	Incidence of Treatment-Related Adverse Events [Safety and Tolerability]	Measured by adverse event severity and quantity	6 Months