What side effects are associated with this type of intervention?

Common treatments for laryngeal cancer, particularly those involving voice prostheses and stomal occlusion like the Blom-Singer SpeakFree HME, can lead to side effects such as stoma stenosis, leakage via the tracheoesophageal fistula, and complications from radiation therapy including pain, xerostomia, and swallowing difficulties. Patients may also face challenges with voice quality and often require ongoing speech therapy.

What prior FDA approvals exist?

FDA approvals for the treatment of laryngeal cancer have primarily focused on surgical interventions, radiation therapy, and chemotherapy. Devices like the Blom-Singer SpeakFree HME, which facilitate hands-free stomal occlusion and heat and moisture exchange, are used post-laryngectomy to improve the quality of life for patients by aiding in speech and reducing complications associated with stoma care. While specific FDA approvals for such devices are not detailed, they are an important part of the rehabilitative process following primary cancer treatments.

What other types of research exist?

A promising alternative to the Blom-Singer SpeakFree HME for laryngeal cancer patients is the Provox voice prosthesis. It features low-resistance, self-retaining properties, and ease of maintenance, with good speech quality reported in 91% of patients. The Provox system also allows for quick outpatient replacement, making it a convenient option for patients.

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SpeakFree HME for Post-Laryngectomy Voice Restoration (SPEAKFREE Trial)

N/A

Recruiting

Led By Mario A Landera, SLP.D.

Research Sponsored by University of Miami

Eligibility Criteria Checklist

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

Must have

Males and non-pregnant females over the age of 18.

Patients must demonstrate fluent tracheoesophageal speech (i.e., maximum phonation time of at least 5 seconds during 3 consecutive trials).

Must not have

Patients who have an underlying neurologic condition potentially impacting speech.

Patients that received a total laryngectomy at non-UM institutions.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new hands-free device that helps people who use a voice prosthesis to speak more easily. It keeps the throat area comfortable and allows them to talk without using their hands.

Who is the study for?

This trial is for adults over 18 who've had a total laryngectomy at the University of Miami, use a voice prosthesis for speech, and have been using an HME for at least 3 months. They must be able to speak clearly with their prosthesis and not be undergoing cancer treatment or have conditions affecting speech.

What is being tested?

The study tests the new Blom-Singer SpeakFree hands-free valve HME against traditional methods like digital occlusion and depression of an HME. It focuses on patient preference and satisfaction as well as objective measures of speech quality such as phonation time, syllables per breath, and voice pressure.

What are the potential side effects?

While specific side effects are not detailed in this summary, typical concerns may include discomfort while using different valves or potential changes in voice quality which will be monitored through various speech assessments.

Eligibility Criteria

Inclusion Criteria

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

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I am over 18 and not pregnant.

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I can speak clearly through my voice prosthesis for at least 5 seconds.

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I had my voice box removed at UM and have used a voice prosthesis for over 6 months.

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My surgical wounds have completely healed.

Exclusion Criteria

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

Select...

I have a condition that affects my ability to speak.

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I had my voice box removed at a different hospital.

Select...

I am currently undergoing treatment for head and neck cancer.

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I have difficulty speaking clearly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Satisfaction as measured by VAS

Voice Quality: Patient Rating

Secondary study objectives

Change in Maximum Phonation Time

Change in Syllables Per Breath

Change in Voice Quality: Clinician Rating

+1 more

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: SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve GroupExperimental Treatment3 Interventions

Participants will be fitted to use a hand free HME device over their stoma in order to communicate with a voice prosthesis for one month. The participants will also serve as their own control performing voicing and speech tasks using digital occlusion and digital depression HME.

0 / 8Eligibility 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 laryngeal cancer include surgery, radiation therapy, and chemotherapy. Surgery often involves removing the tumor and may include partial or total laryngectomy, which can impact speech and breathing. Radiation therapy uses high-energy rays to target and kill cancer cells, while chemotherapy employs drugs to destroy cancer cells throughout the body. These treatments aim to eradicate cancer while preserving as much function as possible. For laryngeal cancer patients, maintaining the ability to speak and breathe comfortably is crucial. Devices like the Blom-Singer SpeakFree HME, which facilitate hands-free stomal occlusion and heat and moisture exchange, are essential as they help improve speech quality and respiratory function post-surgery, enhancing overall quality of life.

Relation between mood, social support and the quality of life in patients with laryngectomies.