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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) Therapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) | Radiation | Twice weekly ALTENS therapy for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Related Adverse Events [Safety and Tolerability] | Measured by adverse event severity and quantity | 6 Months |
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Inclusion Criteria:
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
Pregnancy or the possibility of pregnancy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Kay Winchell | Contact | (585) 273-4839 | Marykay_Winchell@URMC.Rochester.edu | |
| Michael Cummings | Contact | (585) 275-9993 | Michael_Cummings@URMC.Rochester.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Recruiting | Rochester | New York | 14642 | United States |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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