ProvoxLife Heat-Moisture Exchanger for Neck Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Active malignancy, Cognitive limitations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the frequency of ProvoxLife heat-moisture exchanger (HME) system use after a total laryngectomy (removal of the voice box). The goal is to identify factors influencing usage to improve lung function in these individuals. Participants will undergo evaluations, exams, and complete questionnaires about their health, communication, and quality of life. This trial suits those who have had or plan to have a total laryngectomy and are using or ready to start using an HME system. Participants must be able to complete questionnaires in English and manage their own care.

As an unphased trial, this study allows participants to contribute to foundational research that could enhance post-laryngectomy care and improve quality of life for future patients.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the ProvoxLife heat-moisture exchanger system is safe for patients with a total laryngectomy?

Research has shown that ProvoxLife heat-moisture exchangers (HMEs) are safe and well-tolerated for individuals who have undergone a total laryngectomy. The ProvoxLife HME aids these individuals by keeping the air moist and reducing the effort needed to breathe, thus making daily activities more comfortable.

One study examined the long-term use of ProvoxLife HMEs and found them helpful in managing lung symptoms for those who have had a laryngectomy. This indicates that the ProvoxLife HME is not only effective but also safe for extended use.

Additionally, tests have confirmed the ProvoxLife system's ability to maintain air moisture during breathing, which is crucial for lung health after a laryngectomy. Overall, evidence supports that ProvoxLife HMEs are a safe and effective choice for those needing breathing support after this surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ProvoxLife Heat-Moisture Exchanger (HME) trial because it explores how this innovative system can improve the quality of life for individuals with a tracheoesophageal puncture (TEP) and laryngectomy stoma. Unlike standard treatments, which often focus on basic functionality, ProvoxLife aims to enhance speech and swallowing, while also considering overall well-being and activity levels. By assessing how well patients can communicate and engage in physical activities, this trial seeks to uncover more about the comprehensive benefits of using the ProvoxLife HME system.

What evidence suggests that the ProvoxLife HME system is effective for improving lung function in patients with a total laryngectomy?

Studies have shown that the ProvoxLife heat-moisture exchanger (HME) can help people who have had their voice box removed breathe better. Research indicates that it reduces problems like coughing and shortness of breath. In one study, patients experienced better lung health and fewer breathing issues. Another study found that the HME improved voice quality. Overall, these findings suggest that the ProvoxLife HME system effectively helps patients breathe more easily and speak more clearly after surgery. Participants in this trial will undergo evaluations and complete questionnaires to assess the impact of the ProvoxLife HME system on their symptoms, communication ability, and quality of life. ^{6 7 8 9 10}

Who Is on the Research Team?

Katherine A Hutcheson

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Using or ready for fit of HME system

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Participants undergo speech and swallow evaluation and examination of tracheoesophageal puncture and laryngectomy stoma. They also complete questionnaires about the ProvoxLife HME system and related factors.

1 day

1 visit (in-person)

Follow-up Evaluation

Participants complete follow-up questionnaires about the ProvoxLife HME system, symptoms, and quality of life 3 months post-ProvoxLife.

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ProvoxLife Adoption Trends for Heat-Moisture Exchanger

How Is the Trial Designed?

Group I: Observational (evaluation, examination, questionnaire) Experimental Treatment 4 Interventions

Patients undergo speech and swallow evaluation by speech pathologist or study staff member and examination of TEP and laryngectomy stoma. Patients also complete questionnaires over 30 minutes about use the ProvoxLife HME system, symptoms, ability to communicate, exercise and physical activity levels, and quality of life at baseline and 3 months post-ProvoxLife.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05036330

ProvoxLife Adoption Trends for Heat-Moisture Exchanger To determine clinical and patient factors associated with patterns of use of the ProvoxLife HME system for pulmonary rehabilitation after total laryngectomy.

2. clinicaltrial.be clinicaltrial.be/en/details/39463?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_eligible=0&only_active=0

ProvoxLife Adoption Trends for Heat-Moisture Exchanger -... I. To explore outcomes associated with patterns of ProvoxLife HME system. II. To explore factors associated with post-laryngectomy outcomes.

3. atosmedical.com atosmedical.com/healthcare-professionals/laryngectomy/provox-life-ward

Clinical evidence supporting Provox Life – Ward study New clinical study shows changes in pulmonary outcomes as a result of implementing a Day and Night regimen with Heat and Moisture Exchangers (HMEs)

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11625442/

An Exploratory Study on the Efficacy of a New Heat ... We showed that the new HME can improve respiratory symptoms, such as the number of coughs per day, degree of breathlessness, and nocturnal HME use.

5. researchgate.net researchgate.net/publication/364698608_Multicenter_Study_Assessing_Effects_of_Heat_and_Moisture_Exchanger_Use_on_Respiratory_Symptoms_and_Voice_Quality_in_Laryngectomized_Individuals

Multicenter Study Assessing Effects of Heat and Moisture ... CONCLUSION: The observed decrease in pulmonary symptoms and improvement in voice quality confirm earlier reports from the Netherlands, United ...

6. atosmedical.com atosmedical.com/laryngectomy/provox-life/provox-life-heat-and-moisture-exchangers

Provox Life Heat and Moisture Exchangers Provox Life Energy HME is an HME that has good humidification and low breathing resistance, which is perfect for when you are physically active. So now you can ...

7. medline.com medline.com/product/Provox-Life-Go-Heat-and-Moisture-Exchangers-HME/Z05-PF277027

Provox Life Go Heat and Moisture Exchangers (HME) Designed to make it easy to breathe when engaging in daily activities · Humidification with low breathing resistance · Low-profile and discreet look for everyday ...

8. atosmedical.com atosmedical.com/wp-content/uploads/sites/2/2022/12/literature-review-provox-hmes.pdf

Provox® and Provox® LifeTM HMEs and HMEFs During a total laryngectomy, the entire larynx is irreversibly removed, which leads to a permanent disconnection of the upper and lower airways.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06084611

Long Term Effects of Heat and Moisture Exchangers (HMEs) Study Overview. Brief Summary. Assessment of long term effect of Provox Life HME use on pulmonary symptoms in laryngectomized patients.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9878367/

Mixed Methods Study on the Expected Effectiveness - PMC In this study, 5 new HMEs (Provox Life) specialized for situational use with improved humidification capacities were evaluated.