Head and Neck CancerNCT04805528
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
A study testing Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) in people with Head and Neck Cancer, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2022to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester
Rochester, New York, 14642
Therese Smudzin, 585-275-7848, Therese_Smudzin@urmc.rochester.edu
About this study
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
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)
- Keywords
- Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS), Head and Neck Cancer, dry mouth
- Medical subject headings
- Head and Neck Neoplasms, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)Radiation
Twice weekly ALTENS therapy for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 Months
Secondary outcomes (1)
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Measured by adverse event severity and quantity
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start10 Mar 2022
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Cummings, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805528
- Sponsor's protocol ID
- RHAN20083
- Status last verified
- Sep 2025
- First submitted
- 15 Mar 2021
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04805528
- Acronym / sponsor ID
- RHAN20083
- Conditions
- Head and Neck Cancer
- Keywords
- Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS), Head and Neck Cancer, dry mouth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) Therapy | Experimental | Radiation: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)Twice weekly ALTENS therapy for 12 weeks | Radiation | Experimental: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) Therapy |
Primary outcome
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
Measure by responses to XeQoL questionnaire
1 secondary outcome
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Time frame: 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) in people with Head and Neck Cancer, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Kay Winchell ((585) 273-4839, Marykay_Winchell@URMC.Rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.