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New treatment option for Head and Neck Cancer
Official title 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
ClinicalTrials.gov ID: NCT04805528
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Unstable Angina
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.