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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS).
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Radiation Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)
Twice weekly ALTENS therapy for 12 weeks
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 [Time frame: 6 Months]
Secondary outcome measures (1)
- Incidence of Treatment-Related Adverse Events [Safety and Tolerability] [Time frame: 6 Months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Rochester — Rochester
Identifiers
NCT: NCT04805528 · RHAN20083