ALTENS for Dry Mouth in Head and Neck Cancer Patients

Overseen By Mary Kay Winchell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Unstable angina, Pacemaker, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a therapy similar to acupuncture, called ALTENS (Acupuncture-Like Transcutaneous Electrical Nerve Stimulation), can relieve dry mouth in individuals who have undergone radiation treatment for head and neck cancer. ALTENS uses small electrical impulses to stimulate specific points on the body. The aim is to determine if this method can improve dry mouth symptoms, which commonly occur after radiation therapy. Suitable candidates for this trial include those who have received radiation to the head and neck, experience dry mouth, and have been cancer-free for at least three months. As an unphased trial, this study provides a unique opportunity to investigate innovative treatment options for dry mouth relief.

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 prior data suggests that this acupuncture-like electrical therapy is safe for head and neck cancer patients?

Research shows that Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) is generally well-tolerated. Studies have examined ALTENS as a treatment for dry mouth in patients with head and neck cancer, suggesting it is a safe option, with many patients experiencing the treatment without major issues.

For example, one study found that ALTENS helped manage symptoms without causing serious side effects. Patients reported the therapy was easy to undergo, with only mild discomfort from the electrodes. Another study confirmed these results, recommending ALTENS as a possible treatment due to its safety.

Although the FDA has not specifically approved ALTENS for treating dry mouth in cancer patients, its use in other conditions suggests it is safe. Overall, current research supports ALTENS as a safe and potentially effective way to treat dry mouth after radiation therapy, with few reports of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) for treating dry mouth in head and neck cancer patients because it offers a non-invasive approach that differs from traditional methods like saliva substitutes and medications. ALTENS uses small electrodes placed on the skin to deliver low-level electrical impulses, stimulating the body's own processes to potentially improve saliva production. This method is appealing because it avoids the side effects associated with systemic drugs, offering a safer, targeted alternative.

What evidence suggests that ALTENS is effective for treating dry mouth in head and neck cancer patients?

Research has shown that acupuncture-like transcutaneous electrical stimulation (ALTENS), which participants in this trial will receive, may help alleviate dry mouth in head and neck cancer patients who have undergone radiation therapy. In earlier studies, ALTENS significantly improved symptoms of dry mouth, or xerostomia, by increasing saliva production. Another study found that ALTENS enhanced patients' quality of life by reducing the discomfort associated with dry mouth. ALTENS works by sending gentle electrical signals through the skin, which appears to stimulate saliva production. This evidence suggests that ALTENS could be a useful option for managing radiation-induced dry mouth. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Published Research Related to This Trial

Transcutaneous electrical nerve stimulation (TENS) has been shown to significantly increase saliva production in patients with xerostomia following radiotherapy for head and neck cancer, based on a systematic review of five studies involving 280 patients.

TENS therapy is safe, with no reported adverse effects, and is most effective when started daily alongside radiotherapy, although further research is needed to determine the optimal settings for treatment.

NCBI (Pubmed)

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. Salimi, F., Saavedra, F., Andrews, B., et al.[2023]

A case study of a 50-year-old man with xerostomia, 8 years post-radiation treatment, showed significant improvement in symptoms after using a commercially available ALTENS unit at home for 20 minutes daily over 8 weeks.

The patient's quality of life score related to xerostomia dropped dramatically from 20 to 1, indicating that self-administered ALTENS therapy can be effective even long after radiation treatment.

NCBI (Pubmed)

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. Iovoli, AJ., Singh, AK.[2023]

In a phase 2 trial involving 48 patients with head and neck cancer, acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) showed a high compliance rate of 94%, indicating that the treatment can be effectively delivered in a multicenter setting.

After 12 weeks of ALTENS treatment, 86% of patients reported a significant reduction in xerostomia symptoms, with an average improvement of 35.9%, suggesting that ALTENS may be a beneficial intervention for managing radiation-induced dry mouth.

NCBI (Pubmed)

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. Wong, RK., James, JL., Sagar, S., et al.[2022]

In a study involving 60 head and neck cancer patients, acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) did not significantly improve saliva production or reduce xerostomia symptoms compared to standard mouth care.

The primary endpoint, measured by the RIXVAS score at 3 months, showed no significant difference between the ALTENS group and the control group, indicating that ALTENS is not recommended for preventing radiation-induced xerostomia.

NCBI (Pubmed)

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. Wong, RK., Sagar, SM., Chen, BJ., et al.[2018]

In a study of 30 patients with head and neck cancer experiencing xerostomia, both acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) treatment regimens (four times weekly for 6 weeks and twice weekly for 12 weeks) were found to be safe and well tolerated, with no significant adverse events reported.

Both treatment schedules resulted in similar improvements in xerostomia symptoms over 15 months, indicating that either regimen can be effectively used to manage dry mouth in patients undergoing chemoradiation therapy.

NCBI (Pubmed)

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. Iovoli, AJ., Ostrowski, A., Rivers, CI., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4431932/

Results of RTOG 0537 Phase 3 Study This report presents the analysis of the RTOG 0537 multi-center randomized study that compared acupuncture-like transcutaneous stimulation (ALTENS) to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02474095

Acupuncture-Like Transcutaneous Electrical Nerve ... This randomized pilot clinical trial studies alternate schedules for acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) in treating dry ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6358275/

Accupuncture-like transcutaneous electrical nerve ... Accupuncture-like transcutaneous electrical nerve stimulation (ALTENS) therapy has been shown in prospective studies to be effective in the treatment of ...

4. medsci.org medsci.org/v22p2802.pdf

Efficacy of Acupuncture in Managing Radiation-Induced ... Additionally, acupuncture demonstrated significant benefits in reducing xerostomia symptoms and improving quality of life scores compared to ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301603005728

head and neck A Phase I–II study in the use of acupuncture ... Recent studies have suggested that acupuncture may improve radiation-induced xerostomia with an increase in the median salivary flow rate and sustained ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2049080121000959

Trans-cutaneous electrical nerve stimulation to treat dry ... Transcutaneous electrical nerve stimulation technique shows promise in treating xerostomia in patients with head and neck cancer.

7. liebertpub.com liebertpub.com/doi/full/10.1089/acm.2019.0131

Two- Versus Four-Times Weekly Acupuncture-Like ... A Phase I-II study in the use of acupuncture-like transcutaneous nerve stimulation in the treatment of radiation-induced xerostomia in head-and-neck cancer ...