Clinical trial NCT04805528: 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
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)
Head and Neck Cancer
dry mouth
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: 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
timeFrame: 6 Months
Secondary outcomes:
measure: Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
timeFrame: 6 Months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References: