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ALTENS for Dry Mouth in Head and Neck Cancer Patients

N/A
Recruiting
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjective complaint of dry mouth
Previous radiation to the head and neck with a dose > 50 Gy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is to study if acupuncture-like electrical therapy can help with dry mouth in patients who have had radiation treatment for head and neck cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the side effects of ALTENS aren't detailed here, similar treatments may cause mild discomfort or skin irritation at the site of electrode placement. Serious side effects are rare but could include aggravation of existing symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I often feel my mouth is dry.
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I have received radiation treatment to my head or neck area with a dose over 50 Gy.
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I do not have any active cancer in my head or neck area.
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It's been over 3 months since my last treatment and my scans show no active cancer.
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I am older than 18 years.
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I can attend ALTENS therapy sessions for 12 weeks.
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My gender or ethnicity does not affect my eligibility.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) TherapyExperimental Treatment1 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 Location

Who is running the clinical trial?

University of RochesterLead Sponsor
830 Previous Clinical Trials
516,576 Total Patients Enrolled

Media Library

Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) Clinical Trial Eligibility Overview. Trial Name: NCT04805528 — N/A
Head and Neck Cancers Research Study Groups: Experimental: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) Therapy
Head and Neck Cancers Clinical Trial 2023: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) Highlights & Side Effects. Trial Name: NCT04805528 — N/A
Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04805528 — N/A

Frequently Asked Questions

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

How many participants are presently part of this research endeavor?

"Affirmative. Data available on clinicaltrials.gov attests that this medical trial, which was first made public on March 10th 2022, is actively searching for participants. A total of 75 patients will be accepted across a single site."

Answered by AI

Is recruitment for this experiment currently underway?

"Affirmative. According to the information found on clinicaltrials.gov, this study is still recruiting for participants at one location. The initial posting dates back to March 10th 2022 and was last modified on June 7th 2022; 75 recruits are needed in total."

Answered by AI
~30 spots leftby May 2025