What is the mechanism of action of this treatment?

Common treatments for Head and Neck Cancers (HNC) include radiotherapy and chemoradiotherapy, which work by damaging the DNA of cancer cells, leading to their death and reducing tumor size. These treatments are essential for targeting the primary tumor and potential metastases but can also harm surrounding healthy tissues, causing side effects like dysphagia, laryngeal edema, and xerostomia. Supportive therapies such as Expiratory Muscle Strength Training (EMST) aim to strengthen the expiratory muscles, improving swallowing function and reducing aspiration risk. This is crucial for HNC patients as it helps mitigate some of the adverse effects of radiotherapy and chemoradiotherapy, thereby enhancing their quality of life and overall health.

What side effects are associated with this type of intervention?

Common treatments for head and neck cancers, such as radiation therapy and chemoradiotherapy, often lead to side effects including dysphagia (difficulty swallowing), laryngeal edema (swelling of the larynx), xerostomia (dry mouth), and reduced respiratory muscle function. These treatments can also cause generalized fatigue, decreased exercise capacity, and voice changes. The addition of chemotherapy can exacerbate these side effects, particularly increasing the severity of dysphagia.

What prior FDA approvals exist?

FDA-approved treatments for head and neck cancers typically include radiotherapy, chemoradiotherapy, and various pharmacologic agents. Commonly used drugs in these treatments are cisplatin, which is often used in combination with radiotherapy, and other chemotherapeutic agents. While specific FDA approvals for treatments directly aimed at improving swallowing function in head and neck cancer patients are not detailed, therapies like Expiratory Muscle Strength Training (EMST) are being studied to maintain or improve oropharyngeal swallow function during cancer treatment. These studies highlight the ongoing efforts to address the side effects of cancer treatments, such as dysphagia, to improve patients' quality of life.

What other types of research exist?

Promising alternatives to Expiratory Muscle Strength Training for improving swallowing function in Head and Neck Cancer patients include: 1) Resistance training of swallowing muscles, which has shown positive effects in older individuals with dysphagia. 2) Manual lymphatic drainage, which has been effective in managing lymphedema and may indirectly benefit swallowing function by reducing related symptoms. 3) Progressive resistance training, which has been effective in preventing lymphedema and may also improve overall muscle function.

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EMST for Swallowing Disorders in Head and Neck Cancer Patients

N/A

Recruiting

Led By Barbara Pauloski

Research Sponsored by University of Wisconsin, Milwaukee

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

New diagnosis of cancer in the oral cavity, oropharynx, hypopharynx, or larynx

Age 18 or older and able to provide consent

Must not have

Prior history of head and neck radiotherapy

Primary surgery to the head and neck (neck dissection is permitted)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Summary

This trial is testing whether a breathing exercise called Expiratory Muscle Strength Training (EMST) can help patients with head and neck cancer who are undergoing radiation therapy or chemoradiotherapy improve their swallowing. The exercise aims to make the muscles used for breathing out stronger, which may also help with swallowing. EMST is an intervention for patients with oropharyngeal dysphagia and has been proven effective in previous studies.

Who is the study for?

This trial is for adults over 18 with a new diagnosis of cancer in the oral cavity, oropharynx, hypopharynx, or larynx who are about to undergo radiation therapy with or without chemotherapy. Participants must be able to use and maintain a seal on the EMST150 device. Those with prior head and neck surgery (except neck dissection), previous radiotherapy, non-HNCA related swallowing issues, progressive neurological conditions affecting muscle strength, or certain primary cancers are excluded.

What is being tested?

The study tests whether expiratory muscle strength training (EMST) can help people with head and neck cancer maintain safe and efficient swallowing during their treatment with radiation therapy or chemoradiotherapy. It's a randomized trial where participants will either receive EMST or not by chance.

What are the potential side effects?

While specific side effects of EMST aren't detailed here, general risks may include discomfort from using the device, fatigue from exercises, potential soreness in throat muscles due to training intensity, and possible exacerbation of existing swallowing difficulties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer is newly diagnosed and located in my mouth or throat.

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I am 18 or older and can give my consent.

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I can use and hold the EMST150 device in my mouth properly.

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I am scheduled for radiotherapy, with or without chemotherapy.

Exclusion Criteria

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

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I have had radiotherapy for head or neck cancer before.

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I have had surgery on my head or neck, but a neck dissection is allowed.

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My cancer originated in the nasopharynx, sinuses, salivary glands, or skin.

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I have a condition like ALS or Parkinson's that is getting worse.

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The origin of my cancer is unknown.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feeding-tube-free food intake (days)

Secondary study objectives

Extent of hyoid movement (mm)

Penetration-Aspiration Scale rating (number)

Presence of pharyngeal residue (dichotomous)

+2 more

Other study objectives

Eating Assessment Tool (EAT-10) (number)

M.D. Anderson Dysphagia Inventory (MDADI) (number)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active EMST + Standard CareExperimental Treatment1 Intervention

Patients randomized to the Active EMST + Standard Care arm (ACTIVE) will use the EMST150 device as packaged, i.e. following package instructions with a device that has its valve spring maintained.

Group II: Sham EMST + Standard CarePlacebo Group1 Intervention

Those randomized to the Sham EMST + Standard Care arm (SHAM) will use an EMST150 device that has been modified by removing the internal spring, which allows the valve to open in response to airflow through the device regardless of the amount of pressure generated.

0 / 9Eligibility 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 (HNC) include radiotherapy and chemoradiotherapy, which work by damaging the DNA of cancer cells, leading to their death and reducing tumor size. These treatments are essential for targeting the primary tumor and potential metastases but can also harm surrounding healthy tissues, causing side effects like dysphagia, laryngeal edema, and xerostomia. Supportive therapies such as Expiratory Muscle Strength Training (EMST) aim to strengthen the expiratory muscles, improving swallowing function and reducing aspiration risk. This is crucial for HNC patients as it helps mitigate some of the adverse effects of radiotherapy and chemoradiotherapy, thereby enhancing their quality of life and overall health.

Change in dysphagia and laryngeal function after radical radiotherapy in laryngo pharyngeal malignancies - a prospective observational study.Swallowing therapy and progressive resistance training in head and neck cancer patients undergoing radiotherapy treatment: randomized control trial protocol and preliminary data.Effects of exercise on swallowing and tongue strength in patients with oral and oropharyngeal cancer treated with primary radiotherapy with or without chemotherapy.