What side effects are associated with this type of intervention?

Common treatments for head and neck cancers include radiation therapy, chemotherapy, and various forms of acupuncture and electrical stimulation therapies. Radiation therapy often leads to side effects such as xerostomia (dry mouth), mucositis, and dysphagia. Chemotherapy can cause nausea, vomiting, fatigue, and increased risk of infection. Acupuncture and acupuncture-like electrical therapies are generally well-tolerated but can occasionally cause mild adverse events such as a warm sensation, numbness, redness, itching, tingling, and muscle spasms. These therapies aim to alleviate symptoms like dry mouth and pain, but their effectiveness and side effects can vary.

What prior FDA approvals exist?

The FDA has approved various treatments for Head and Neck Cancers, including surgical interventions, radiation therapy, and pharmacologic agents like cetuximab, pembrolizumab, and nivolumab. While there is limited specific information on FDA approvals for non-pharmacological treatments like Acupuncture-like Electrical Therapy, devices such as transcutaneous electrical nerve stimulation (TENS) and transcranial magnetic stimulation (TMS) have been approved for other conditions and show potential for symptom management in cancer patients. These devices aim to alleviate symptoms such as pain and dry mouth, similar to the goals of Acupuncture-like Electrical Therapy being studied for salivary gland function stimulation.

What other types of research exist?

Promising novel alternatives to Acupuncture-like Electrical Therapy for head and neck cancer patients include pilocarpine, a medication that stimulates saliva production. Additionally, advancements in neuromodulation techniques, such as transcutaneous supraorbital nerve stimulation and remote electrical neuromodulation, show potential for pain and symptom management, which could be adapted for xerostomia treatment. Further research into these methods and their application to salivary gland stimulation is warranted.

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ALTENS for Dry Mouth in Head and Neck Cancer Patients

Q: What is the mechanism of action of this treatment?

Common treatments for head and neck cancers include surgery, radiation therapy, chemotherapy, and integrative therapies like acupuncture and acupuncture-like electrical therapy. Surgery and radiation therapy primarily work by physically removing or destroying cancer cells. Chemotherapy uses drugs to kill rapidly dividing cells, including cancer cells. Acupuncture-like electrical therapy, such as the stimulation of salivary gland function, aims to alleviate symptoms like xerostomia (dry mouth) by enhancing salivary flow through electrical stimulation of the nerves and tissues associated with salivary glands. Understanding these mechanisms is crucial for patients as it helps them comprehend how each treatment targets their cancer or alleviates symptoms, enabling informed decisions about their care.

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

Minimum of 3 months post initial curative therapy with no evidence of active disease by standard of care surveillance scans for said disease site

Previous radiation to the head and neck with a dose > 50 Gy

Must not have

Age under 18 years of age

Severe COPD with exacerbation causing hospitalization within the last 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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

Select...

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

Select...

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

Select...

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

Select...

I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Select...

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

Select...

I have had heart rhythm problems in the last 6 months.

Select...

I have not been hospitalized for heart problems in the last 6 months.

Select...

I cannot attend ALTENS therapy sessions.

Select...

I have unstable chest pain.

Select...

I am willing and able to undergo chemoradiation therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for head and neck cancers include surgery, radiation therapy, chemotherapy, and integrative therapies like acupuncture and acupuncture-like electrical therapy. Surgery and radiation therapy primarily work by physically removing or destroying cancer cells. Chemotherapy uses drugs to kill rapidly dividing cells, including cancer cells. Acupuncture-like electrical therapy, such as the stimulation of salivary gland function, aims to alleviate symptoms like xerostomia (dry mouth) by enhancing salivary flow through electrical stimulation of the nerves and tissues associated with salivary glands. Understanding these mechanisms is crucial for patients as it helps them comprehend how each treatment targets their cancer or alleviates symptoms, enabling informed decisions about their care.

A randomized, controlled phase II trial of maxillofacial and oral massage in attenuating severe radiotherapy-induced oral mucositis and lipid metabolite changes in nasopharyngeal carcinoma.Acupuncture for Chemoradiation Therapy-Related Dysphagia in Head and Neck Cancer: A Pilot Randomized Sham-Controlled Trial.