Head and Neck Cancer
Conditions
Keywords
Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS), Head and Neck Cancer, dry mouth
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.
Interventions
RADIATIONAcupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)
Twice weekly ALTENS therapy for 12 weeks
Sponsors
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Related Adverse Events [Safety and Tolerability] | 6 Months | Measured by adverse event severity and quantity |
Countries
United States
Contacts
Primary ContactMary Kay Winchell
Backup ContactMichael Cummings
Outcome results
None listed