Malignant Head and Neck NeoplasmNCT05036330
ProvoxLife Adoption Trends for Heat-Moisture Exchanger
An observational study of Malignant Head and Neck Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study examines factors that affect how often patients who have a total laryngectomy use a ProvoxLife heat-moisture exchanger (HME) system to help improve their lung function. ProvoxLife HMEs are single use heat- and moisture exchangers for patients breathing through a tracheostoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Head and Neck Neoplasm
- What is being tested?
- Clinical Evaluation, Physical Examination and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2021to 2 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients using or planning to use HME as part of standard care
Who may be able to join
- Adults >= 18 years of age planned for or status post total laryngectomy
- Using or ready for fit of HME system
Who cannot join
- Active malignancy if post-total laryngectomy (TL) at the time of enrollment
- Unable to complete questionnaires in English language
- The primary endpoint derives from a study specific questionnaire, due to limited resources, is only available in English language
- Cognitive or other limitations that preclude independent self-care or completion of questionnaires
- Cognitive or other limitations that preclude independent self-care or completion of questionnaires will be assessed in the screening interview by the clinical or research team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ProvoxLife® Adoption Trends for Heat-Moisture Exchanger (HME): The PATH Registry
This study examines factors that affect how often patients who have a total laryngectomy use a ProvoxLife heat-moisture exchanger (HME) system to help improve their lung function. ProvoxLife HMEs are single use heat- and moisture exchangers for patients breathing through a tracheostoma. Information from this study may help doctors learn more about factors associated with patterns of use and how often patients use the ProvoxLife HME system.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine clinical and patient factors associated with patterns of use of the ProvoxLife HME system for pulmonary rehabilitation after total laryngectomy.
SECONDARY OBJECTIVES:
- To explore outcomes associated with patterns of ProvoxLife HME system. II. To explore factors associated with post-laryngectomy outcomes.
OUTLINE:
Patients undergo speech and swallow evaluation by speech pathologist or study staff member and examination of tracheoesophageal puncture (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.
- Conditions
- Malignant Head and Neck Neoplasm
- Being tested
- Clinical Evaluation, Physical Examination, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical EvaluationOther
Also called Clinical Assessment
Undergo speech and swallow evaluation
Physical ExaminationProcedure or surgery
Also called Assessment, General Examination
Undergo examination of TEP and laryngectomy stoma
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete questionnaires
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Observational (evaluation, examination, questionnaire) | 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. Receives: Other: Clinical Evaluation; Procedure: Physical Examination; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine clinical and patient factors associated with patterns of use of the ProvoxLife HME system for pulmonary rehabilitation after total laryngectomy.
Measured: Up to 3 months post-ProvoxLife HME
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start21 May 2021
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Head and Neck NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Katherine A Hutcheson, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036330
- Sponsor's protocol ID
- 2020-1114
- Other IDs
- NCI-2021-08784, 2020-1114
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2021
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProvoxLife® Adoption Trends for Heat-Moisture Exchanger (HME): The PATH Registry
- ClinicalTrials.gov ID
- NCT05036330
- Acronym / sponsor ID
- 2020-1114
- Conditions
- Malignant Head and Neck Neoplasm
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 May 2021 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines factors that affect how often patients who have a total laryngectomy use a ProvoxLife heat-moisture exchanger (HME) system to help improve their lung function. ProvoxLife HMEs are single use heat- and moisture exchangers for patients breathing through a tracheostoma. Information from this study may help doctors learn more about factors associated with patterns of use and how often patients use the ProvoxLife HME system.
Detailed description
PRIMARY OBJECTIVE:
- To determine clinical and patient factors associated with patterns of use of the ProvoxLife HME system for pulmonary rehabilitation after total laryngectomy.
SECONDARY OBJECTIVES:
- To explore outcomes associated with patterns of ProvoxLife HME system. II. To explore factors associated with post-laryngectomy outcomes.
OUTLINE:
Patients undergo speech and swallow evaluation by speech pathologist or study staff member and examination of tracheoesophageal puncture (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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (evaluation, examination, questionnaire) | – | Other: Clinical Evaluation, Procedure: Physical Examination, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients using or planning to use HME as part of standard care
Key inclusion criteria (2 listed)
- Adults >= 18 years of age planned for or status post total laryngectomy
- Using or ready for fit of HME system
Key exclusion criteria (5 listed)
- Active malignancy if post-total laryngectomy (TL) at the time of enrollment
- Unable to complete questionnaires in English language
- Cognitive or other limitations that preclude independent self-care or completion of questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical EvaluationAlso: Clinical AssessmentUndergo speech and swallow evaluation | Other | Observational (evaluation, examination, questionnaire) |
| Physical ExaminationAlso: Assessment, General ExaminationUndergo examination of TEP and laryngectomy stoma | Procedure or surgery | Observational (evaluation, examination, questionnaire) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete questionnaires | Other | Observational (evaluation, examination, questionnaire) |
| Questionnaire AdministrationComplete questionnaires | Other | Observational (evaluation, examination, questionnaire) |
Primary outcome
To determine clinical and patient factors associated with patterns of use of the ProvoxLife HME system for pulmonary rehabilitation after total laryngectomy.
Time frame: Up to 3 months post-ProvoxLife HME
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine A Hutcheson principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Head and Neck Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine clinical and patient factors associated with patterns of use of the ProvoxLife HME system for pulmonary rehabilitation after total laryngectomy. (time frame: Up to 3 months post-ProvoxLife HME). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.