ALTENS for Dry Mouth in Head and Neck Cancer Patients

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Rochester

Disqualifiers: Unstable angina, Pacemaker, Pregnancy, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing if using small electrical currents on specific body points can help patients with head and neck cancer who have had radiation treatment to reduce their dry mouth symptoms. This method has been used for skin tumors and has been evaluated for its effectiveness and safety in head and neck cancers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) for dry mouth in head and neck cancer patients?

Research shows that ALTENS can improve saliva flow and reduce dry mouth symptoms in head and neck cancer patients who have undergone radiotherapy. Studies indicate that ALTENS is safe, well-tolerated, and appears to be effective in managing dry mouth symptoms, although it may not be significantly better than standard treatments like pilocarpine. ^{1 2 3 4 5}

Is ALTENS safe for treating dry mouth in head and neck cancer patients?

ALTENS is considered safe and well-tolerated, with studies showing no significant adverse events in patients treated for dry mouth after radiation therapy. ^{1 2 3 4 5}

How does the ALTENS treatment for dry mouth in head and neck cancer patients differ from other treatments?

ALTENS (acupuncture-like transcutaneous electrical nerve stimulation) is unique because it uses electrical stimulation to improve saliva flow, unlike traditional drug treatments like pilocarpine. It is a non-invasive therapy that can be administered at home, offering a novel approach for managing dry mouth in cancer patients. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults over 18 with dry mouth after radiation therapy for head and neck cancer. They must be at least 3 months post-treatment, without active cancer, and able to attend a 12-week ALTENS therapy program. It's not suitable for those with recent severe heart issues, implanted electronic devices, or who are pregnant.

Inclusion Criteria

It's been over 3 months since my last treatment and my scans show no active cancer.

I have received radiation treatment to my head or neck area with a dose over 50 Gy.

I do not have any active cancer in my head or neck area.

Exclusion Criteria

I am under 18 years old.

I was hospitalized for a severe COPD flare-up in the last 6 months.

Pregnancy or the possibility of pregnancy

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) Therapy to alleviate xerostomia

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) (Procedure)

Trial Overview The study tests if acupuncture-like electrical stimulation (ALTENS) can relieve dry mouth in patients who've undergone radiation for head and neck cancers. Participants will receive ALTENS therapy over a period of 12 weeks to evaluate its effectiveness.

Participant Groups

Group I: Experimental: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) Therapy Experimental Treatment 1 Intervention

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Rochester Rochester, NY

Who Is Running the Clinical Trial?

University of Rochester Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Trans-cutaneous electrical nerve stimulation to treat dry mouth (xerostomia) following radiotherapy for head and neck cancer. A systematic review. [2023] A dry mouth or xerostomia is one of the most common long-term complications following radiotherapy for head and neck cancer and has a negative impact on quality of life in cancer survivors. Transcutaneous electrical nerve stimulation (TENS) is a novel approach to improving saliva flow in these patients.

2. Canada pubmed.ncbi.nlm.nih.gov

Phase II Randomized Trial of Acupuncture-Like Transcutaneous Electrical Nerve Stimulation to Prevent Radiation-Induced Xerostomia in Head and Neck Cancer Patients. [2018] Current evidence indicates that acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) can provide sustained benefit for established radiation-induced xerostomia (RIX) symptoms. This is further being evaluated by comparing it with standard treatment (pilocarpine) in a randomized controlled trial. This report studies the potential effectiveness of xerostomia prevention using ALTENS delivered concomitantly with radiotherapy administered to head and neck cancer patients. Sixty patients were randomized to either the treatment group (n = 30) that received ALTENS daily with radiotherapy or the control group (n = 26) that had standard mouth care only. Stimulated and basal unstimulated whole saliva production (WSP) plus RIX symptoms visual analogue score (RIXVAS) were assessed at specific time points. Generalized linear models and generalized estimating equations were used for analysis. RIXVAS at 3 months follow-up after therapy completion was used as the primary study endpoint. The mean RIXVAS for the ALTENS intervention at 3 months was 39.8, which was not significantly different from the control arm value of 40.5. There were no statistically significant differences between the two groups for their mean RIXVAS and WSP at all assessment time points. In conclusion, there was no significant difference in mean WSP and RIXVAS between the two groups, so ALTENS is not recommended as a prophylactic intervention.

3. England pubmed.ncbi.nlm.nih.gov

Accupuncture-like transcutaneous electrical nerve stimulation therapy success using a commercially available unit 8 years post-radiation for xerostomia: a case report. [2023] Accupuncture-like transcutaneous electrical nerve stimulation (ALTENS) therapy has been shown in prospective studies to be effective in the treatment of radiation-induced xerostomia. Those studies treated patients within 27 months from end of radiation with ALTENS delivered in the clinic using a Codetron unit. However, that unit is no longer produced and there is limited data on success of ALTENS when delivered at home.

4. United States pubmed.ncbi.nlm.nih.gov

Two- Versus Four-Times Weekly Acupuncture-Like Transcutaneous Electrical Nerve Stimulation for Treatment of Radiation-Induced Xerostomia: A Pilot Study. [2021] Background: Xerostomia occurs in the majority of patients undergoing chemoradiation therapy for head and neck cancer (HNC). Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) treatment has been studied as an encouraging modality to improve salivary function and related symptoms. The purpose of this study was to compare ALTENS treatment by using a four-times weekly schedule for 6 weeks versus a twice-weekly schedule for 12 weeks with a validated xerostomia scale at 15 months from the start of ALTENS treatment. Materials and Methods: This single-center randomized study was conducted in 30 patients treated with radiotherapy with or without chemotherapy for HNC between 2014 and 2017, who had at least grade 1 or 2 symptomatic dry mouth (xerostomia) according to CTEP NCI Common Terminology Criteria for Adverse Events (CTCAE version 4.0). These patients were randomly assigned to receive ALTENS four-times weekly for 6 weeks or two-times weekly for 12 weeks. The University of Michigan 15-item Xerostomia-related Quality of Life Scale (XeQoLS) was administered at 6, 9, 15, and 21 months from the start of ALTENS treatment. A random-effects generalized linear model was used to model the overall XeQoLS score at the 15-month endpoint; adjusted for a random time effect, a fixed treatment arm, and interaction of time and treatment. Comparison between arms was based on a 0.05 nominal significance level. Results: XeQoLS decreased for all patients (although not statistically for each arm) from a mean of 22 and 21 at baseline (in the four times per week and twice weekly arms) to 12 in both arms at 15 months, with no difference between arms (p = 0.68). There were no attributable grade 1-3 adverse events. Arms were balanced for age, gender, race, and baseline xerostomia. Conclusions: This study demonstrates that both ALTENS regimens are safe, well tolerated, and appear to be equally effective. We now routinely make ALTENS units available for home use.

5. United States pubmed.ncbi.nlm.nih.gov

Phase 2 results from Radiation Therapy Oncology Group Study 0537: a phase 2/3 study comparing acupuncture-like transcutaneous electrical nerve stimulation versus pilocarpine in treating early radiation-induced xerostomia. [2022] In this phase 2 component of a multi-institutional, phase 2/3, randomized trial, the authors assessed the feasibility and preliminary efficacy of acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) in reducing radiation-induced xerostomia.