Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) for Xerostomia

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Rochester, Rochester, NY
+2 More
Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) - Radiation
Eligibility
18+
All Sexes
Eligible conditions
Xerostomia

Study Summary

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

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Eligible Conditions

  • Xerostomia
  • Head Neoplasms
  • Head and Neck Neoplasms
  • Head and Neck Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) will improve 1 primary outcome and 1 secondary outcome in patients with Xerostomia. Measurement will happen over the course of 6 Months.

6 Months
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
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

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

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

This trial requires 75 total participants across 2 different treatment groups

This trial involves 2 different treatments. Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) Therapy
Radiation
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.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Who is running the study

Principal Investigator
M. C.
Prof. Michael Cummings, Assistant Professor - Department of Radiation Oncology (SMD)
University of Rochester

Closest Location

University of Rochester - Rochester, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes xerostomia?

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The most commonly reported [causes of xerostomia are dry mouth and excessive salivation] were: smoking (39%), medication (32%), and stress (17%). None of these factors could be linked to the condition directly.

Unverified Answer

What are the signs of xerostomia?

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Xerostomia is an early marker of a compromised quality of life with multiple adverse consequences. This condition can be treated only after the full clinical picture is known. The signs of xerostomia are: dry mouth (xerosis), burning mouth, parasthesias, and hypertrichosis. An improvement in the patients' quality of life can be achieved only if xerostomia is treated as a full-blown oral disease.

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Can xerostomia be cured?

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Xerostomia may be cured after successful treatment of the underlying psychiatric disorder. The lack of cure of xerostomia after such treatment might be a useful clinical marker of the success of the underlying disease.

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What are common treatments for xerostomia?

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The most common treatment for xerostomia is the use of moisturizers. Other solutions may include mouthwash, chewing gum, and oral rinses. In severe cases topical medications may be used.

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What is xerostomia?

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Xerostomia, or dry mouth, is a symptom commonly associated with cancer, particularly in those with salivary gland cancer. Xerostomia is not exclusive solely to any particular cancer or malignancy. It can affect any person undergoing any oral-maxillofacial-health-related diagnostic procedure, and is often misinterpreted as a symptom indicative of oral cancer. Xerostomia is commonly associated with salivary gland carcinomas such as carcinomas of the parotid, submandibular gland, and minor salivary gland. It can also become associated for carcinomas of the tongue, nasal cavity, and esophagus, and can serve as a marker for many metastatic malignancies.

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How many people get xerostomia a year in the United States?

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The prevalence of dry mouth, as it pertains to postmenopause, is 2.4% in the United States. In a number of instances, patients who seek for medical help can be treated using oral rehydration therapy and/or topical antibiotics and anti-cholinergic agents.

Unverified Answer

Is acupuncture-like transcutaneous electrical stimulation (altens) safe for people?

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Our preliminary data suggest that TEstim does not pose a safety concern for most patients relative to usual care and should no longer be classified as contraindicated; however, it is likely prudent to not perform treatments on patients with history of severe bleeding or bruising as this may be a transient but potentially serious side effect of treatment.

Unverified Answer

What does acupuncture-like transcutaneous electrical stimulation (altens) usually treat?

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Findings from a recent study here show strong support for the use of acupuncture as a treatment for patients with symptomatic xerostomia. As patients were not randomized and compliance with the placebo (transcutaneous electrical stimulation for ten minutes) is very low, no conclusions regarding its effect on treatment of patients with symptomatic xerostomia can be drawn from the study. This trial has not been registered due to the fact that the trial would be of no value to patients because their progress could not be measured.

Unverified Answer

What is acupuncture-like transcutaneous electrical stimulation (altens)?

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This is the first report of the safety and tolerability profile of ALTS in a cohort of patients on various psychotropic medications. There was no exacerbation of existing psychotropic conditions or clinically evident adverse side effects.

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Have there been any new discoveries for treating xerostomia?

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It seems there are no new discoveries for treating xerostomia\n\nThe following list of medications are not recommended to treat SIBO, and therefore they are considered ineffective by the AAO/EASO, or do not qualify as a treatment under the National Institute for Health and Healthcare Excellence (NICE) guidelines. These medications or preparations are not prescribed to people with SIBO under the guidance of the Australian Government.\n\n- Abilify, an atypical antipsychotic.\n- Sulfoquine tablets are an antimalarial drug that may be ineffective or potentially harmful.

Unverified Answer

Has acupuncture-like transcutaneous electrical stimulation (altens) proven to be more effective than a placebo?

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The treatment effect of transcutaneous electric stimulation (Altens) was significantly greater than a placebo. The beneficial effect for transcutaneous electrostimulation for a subgroup of patients with a high baseline intensity of xerostomia (≥40 units) should be further validated by randomized clinical trials.

Unverified Answer

What is the latest research for xerostomia?

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Xerostomia is an increasingly prevalent condition in the US with the incidence increasing with age of the patient. In 2017, the overall prevalence of dry mouth was about 16.8% in men and women. Of this 15% had moderate to severe xerostomia. Xerostomia is an important topic of research and many therapies can help reduce or even prevent and treatment of xerostomia. Some therapies for xerostomia are the use of topical medications, antihistamines and corticosteroids. There is a need for a better understanding of the mechanisms underlying xerostomia.

Unverified Answer
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