LaryngectomyNCT04974801
Assessment of the New Provox Life System for Pulmonary Health and Quality of Life After Total Laryngectomy
A study testing Provox Life in people with Laryngectomy, run by Atos Medical AB at 1 site in Italy.
Trial summary
Background: The benefits of using Heat and Moisture Exchangers (HMEs) for pulmonary rehabilitation after total laryngectomy are widely known. However, current available HMEs do not reach the level of humidification capacity of the nose, and patients adherence to using an HME 24/7 is not always possible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngectomy
- What is being tested?
- Provox Life
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 14 Dec 2020to 21 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Total laryngectomy, irrespective of pharynx reconstruction method
- 18 years or older
- Provox XtraHME user
- Provox Adhesive user
- Longer than 3 months after total laryngectomy
- Longer than 6 weeks after postoperative radiotherapy
Who cannot join
- Medical problems prohibiting the use of HME or adhesive
- Active recurrent or metastatic disease (medical deterioration)
- Recent pulmonary infections/unstable pulmonary condition
- Reduced mobility of arms and/or hands, unable to remove an HME
- Unable to understand the Patient Information and/or unable to give Informed Consent
- Insufficient cognitive ability to handle the HME or adhesive
- LaryButton users
Trial locations and contacts
1 site in 1 country.
Italy1 site
Universita Cattolica del Sacro Cuore di Roma, Faculty of Medicine and Surgery 'Agostino Gemelli'
Roma, 00168
About this study
Official title: A Randomized Cross Over Clinical Trial Assessing the New Provox Life System for Pulmonary Rehabilitation and Quality of Life After Total Laryngectomy
Background: The benefits of using Heat and Moisture Exchangers (HMEs) for pulmonary rehabilitation after total laryngectomy are widely known. However, current available HMEs do not reach the level of humidification capacity of the nose, and patients adherence to using an HME 24/7 is not always possible. Provox Life HMEs and attachments are a new range of HMEs and attachments, with improved humidification/breathability performance, and designed to suit different situations.
Purpose and aim: In this clinical trial, the new Provox Life System was assessed for pulmonary rehabilitation and QoL after total laryngectomy, and compared with currently available HMEs and attachments.
Methods: Forty laryngectomized patients, who were previous users of HMEs, were randomized to Usual Care or Provox Life for 6 weeks, after which a cross-over occurred. Data was collected at baseline, and after the end of each study period. Additionally, patients filled in a diary and tally sheet to record their forced expectorations and coughing.
- Conditions
- Laryngectomy
- Being tested
- Provox Life, Usual Care
- Keywords
- Pulmonary rehabilitation, Quality of Life, Heat and Moisture Exchangers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provox LifeDevice
Use of Provox Life range of HMEs for different situations and their attachments (adhesives and laryngectomy tubes)
Usual CareDevice
Continued Usual Care routines.
| Study group | Role | What they receive |
|---|---|---|
| Provox Life HMEs followed by Usual Care HMEs | Other | Use of Provox Life devices during a period of six weeks followed by use of Usual Care devices during a period of six weeks. Receives: Device: Provox Life; Device: Usual Care |
| Usual Care HMEs followed by Provox Life HMEs | Other | Use of Usual Care devices during a period of six weeks followed by use of Provox Life devices during a period of six weeks. Receives: Device: Provox Life; Device: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of forced mucus expectorations per 24 hours
Patient reported, recorded by Tally sheeting on 3 days
Measured: during week 6 of period 1 and period 2 (each period is 6 weeks)
Secondary outcomes (12)
Average number of (involuntary) dry coughs per 24 hours
Patient reported, recorded by Tally sheeting on 3 days
Measured: during week 6 of period 1 and period 2 (each period is 6 weeks)
Coughing Symptoms (COUS) domain score of CASA-Q
Cough Symptoms (COUS), assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q) questionnaire. CASA-Q score between 0-100, with higher scores meaning less symptoms and less impact.
Measured: Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks)
Coughing Impact (COUI) domain score of CASA-Q
Cough Impact (COUI), assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q) questionnaire. CASA-Q score between 0-100, with higher scores meaning less symptoms and less impact.
Measured: Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks)
Sputum Symptoms (SPUS) domain score of CASA-Q
Sputum Symptoms (SPUS), assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q) questionnaire. CASA-Q score between 0-100, with higher scores meaning less symptoms and less impact.
Measured: Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks)
Sputum Impact (SPUI) domain score of CASA-Q
Sputum Impact (SPUI), assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q) questionnaire. CASA-Q score between 0-100, with higher scores meaning less symptoms and less impact.
Measured: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
Peristomal skin irritation
Recorded by study specific questionnaire on frequency of Skin irritation.
Measured: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
Average number of days with skin irritation
Patient reported, recorded by daily diary keeping the last two weeks of each study period
Measured: during week 5 and week 6 of period 1 and period 2 (each period is 6 weeks)
Quality of Life by EQ-5D-5L
Patient reported, the descriptive system assesses health in five dimensions, from which a health state index score is calculated, range from 0 to 1, with higher scores indicating higher health utility
Measured: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
Frequency of using sleeping medication
Study-specific questionnaire on use of sleeping medications
Measured: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
Average number of hours of HME use per 24 hours
Patient reported, recorded by daily diary keeping the last two weeks of each study period
Measured: during week 5 and week 6 of period 1 and period 2 (each period is 6 weeks)
Situational usage pattern of Provox Life HMEs
Study-specific questionnaire about the situational use of devices
Measured: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
Patient satisfaction with the Provox Life devices
Patient satisfaction with devices through study specific questionnaires.
Measured: At the end of Period 1 (Group A), at the end of Period 2 (Group B) (each period is 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start14 Dec 2020
- Primary completion21 Apr 2021
- Study completion21 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LaryngectomyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single center, randomized, prospective crossover study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atos Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudio Parilla, Dr., Principal investigator, Universita Cattolica del Sacro Cuore di Roma, Faculty of Medicine and Surgery 'Agostino Gemelli'
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974801
- Sponsor's protocol ID
- Prot_Id_3523
- Status last verified
- Mar 2022
- First submitted
- 6 Jul 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Longobardi Y, Galli J, Di Cesare T, D'Alatri L, Settimi S, Mele D, Bussu F, Parrilla C. Optimizing Pulmonary Outcomes After Total Laryngectomy: Crossover Study on New Heat and Moisture Exchangers. Otolaryngol Head Neck Surg. 2022 Dec;167(6):929-940. doi: 10.1177/01945998221086200. Epub 2022 Mar 22.
PubMed 35316144
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross Over Clinical Trial Assessing the New Provox Life System for Pulmonary Rehabilitation and Quality of Life After Total Laryngectomy
- ClinicalTrials.gov ID
- NCT04974801
- Acronym / sponsor ID
- Prot_Id_3523
- Conditions
- Laryngectomy
- Keywords
- Pulmonary rehabilitation, Quality of Life, Heat and Moisture Exchangers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Atos Medical ABIndustry (pharma, biotech, devices)
- Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 23 Jul 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.
Background: The benefits of using Heat and Moisture Exchangers (HMEs) for pulmonary rehabilitation after total laryngectomy are widely known. However, current available HMEs do not reach the level of humidification capacity of the nose, and patients adherence to using an HME 24/7 is not always possible. Provox Life HMEs and attachments are a new range of HMEs and attachments, with improved humidification/breathability performance, and designed to suit different situations.
Purpose and aim: In this clinical trial, the new Provox Life System was assessed for pulmonary rehabilitation and QoL after total laryngectomy, and compared with currently available HMEs and attachments.
Methods: Forty laryngectomized patients, who were previous users of HMEs, were randomized to Usual Care or Provox Life for 6 weeks, after which a cross-over occurred. Data was collected at baseline, and after the end of each study period. Additionally, patients filled in a diary and tally sheet to record their forced expectorations and coughing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center, randomized, prospective crossover study
| Arm | Type | Receives |
|---|---|---|
| Provox Life HMEs followed by Usual Care HMEs | Other | Device: Provox Life, Device: Usual CareUse of Provox Life devices during a period of six weeks followed by use of Usual Care devices during a period of six weeks. |
| Usual Care HMEs followed by Provox Life HMEs | Other | Device: Provox Life, Device: Usual CareUse of Usual Care devices during a period of six weeks followed by use of Provox Life devices during a period of six weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Total laryngectomy, irrespective of pharynx reconstruction method
- 18 years or older
- Provox XtraHME user
- Provox Adhesive user
- Longer than 3 months after total laryngectomy
Key exclusion criteria (7 listed)
- Medical problems prohibiting the use of HME or adhesive
- Active recurrent or metastatic disease (medical deterioration)
- Recent pulmonary infections/unstable pulmonary condition
- Reduced mobility of arms and/or hands, unable to remove an HME
- Unable to understand the Patient Information and/or unable to give Informed Consent
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 |
|---|---|---|
| Provox LifeUse of Provox Life range of HMEs for different situations and their attachments (adhesives and laryngectomy tubes) | Device | Provox Life HMEs followed by Usual Care HMEs, Usual Care HMEs followed by Provox Life HMEs |
| Usual CareContinued Usual Care routines. | Device | Provox Life HMEs followed by Usual Care HMEs, Usual Care HMEs followed by Provox Life HMEs |
Primary outcome
Average number of forced mucus expectorations per 24 hours
Time frame: during week 6 of period 1 and period 2 (each period is 6 weeks)
Patient reported, recorded by Tally sheeting on 3 days
12 secondary outcomes
Average number of (involuntary) dry coughs per 24 hours
Time frame: during week 6 of period 1 and period 2 (each period is 6 weeks)
Coughing Symptoms (COUS) domain score of CASA-Q
Time frame: Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks)
Coughing Impact (COUI) domain score of CASA-Q
Time frame: Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks)
Sputum Symptoms (SPUS) domain score of CASA-Q
Time frame: Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks)
Sputum Impact (SPUI) domain score of CASA-Q
Time frame: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
Peristomal skin irritation
Time frame: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
Average number of days with skin irritation
Time frame: during week 5 and week 6 of period 1 and period 2 (each period is 6 weeks)
Quality of Life by EQ-5D-5L
Time frame: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
Frequency of using sleeping medication
Time frame: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
Average number of hours of HME use per 24 hours
Time frame: during week 5 and week 6 of period 1 and period 2 (each period is 6 weeks)
Situational usage pattern of Provox Life HMEs
Time frame: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
Patient satisfaction with the Provox Life devices
Time frame: At the end of Period 1 (Group A), at the end of Period 2 (Group B) (each period is 6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Results publication: PubMed 35316144Longobardi Y, Galli J, Di Cesare T, D'Alatri L, Settimi S, Mele D, Bussu F, Parrilla C. Optimizing Pulmonary Outcomes After Total Laryngectomy: Crossover Study on New Heat and Moisture Exchangers. Otolaryngol Head Neck Surg. 2022 Dec;167(6):929-940. doi: 10.1177/01945998221086200. Epub 2022 Mar 22.
- Individual participant dataSharing planned: No
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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.
Claudio Parilla, Dr. principal investigator
Universita Cattolica del Sacro Cuore di Roma, Faculty of Medicine and Surgery 'Agostino Gemelli'
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provox Life in people with Laryngectomy, run by Atos Medical AB at 1 site in Italy.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 5 Apr 2022. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Average number of forced mucus expectorations per 24 hours (time frame: during week 6 of period 1 and period 2 (each period is 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04974801, which also lists 1 linked publication.
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 5 Apr 2022.