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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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04805528
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Rochester
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Head and Neck Cancer
Additional Details

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.

Arms & Interventions

Arms

Experimental: Experimental: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) Therapy

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.

Interventions

Radiation: - Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)

Twice weekly ALTENS therapy for 12 weeks

Contact a Trial Team

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University of Rochester, Rochester, New York

Status

Recruiting

Address

University of Rochester

Rochester, New York, 14642

Site Contact

Therese Smudzin

[email protected]

585-275-7848

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