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 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.

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}

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}

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]

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]

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 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]

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]

Citations

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]

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]

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]

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]

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]