LaryngectomyPHRASALNCT04100954
Cost-effectiveness Analysis of Vocal Rehabilitation With Strengthened Tracheoesophageal Voice Implant Prosthesis Versus Standard Voice Prosthesis in Case of Repeated Intra-prosthetic Leakage After Total Laryngectomy
A study testing Reinforced prosthesis and Standard prosthesis in people with Laryngectomy, run by Nantes University Hospital at 13 sites in France.
Trial summary
The purpose of this study is to determine the cost-effectiveness of vocal rehabilitation with reinforced inter-tracheoesophageal voice prosthesis versus standard voice prosthesis in case of repeated intra-prosthetic leakage in total laryngectomy patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngectomy
- What is being tested?
- Reinforced prosthesis and Standard prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 13 sitesFrance
- Study dates
- 21 Jan 2020to 31 Jan 2024
- 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
- Patient treated surgically by total laryngectomy or total pharyngolaryngectomy or total circular pharyngolaryngectomy and carrying a voice prosthesis for at least 12 months
- Patient carrying a standard voice prosthesis and having undergone 2 successive prosthesis replacements within 3 months of interval and/or requiring at least 4 changes in the last 12 months, for intraprosthetic leakage
- Patients carrying a voice prosthesis, irrespective of the mark/model, of diameters between 16 and 20 French, and of length between 6 and 14 mm.
- Prosthetic replacement available under local or general anaesthesia
- Patient with primary cancer remission status
- Patient agreeing to participate in the study and having given oral, express and informed consent
Who cannot join
- Patient with local, regional or metastatic tumor evolution
- Patient who has had a first voice prosthesis for less than 12 months.
- Patient with peri-prosthetic leakage
- Patient presenting a dysfunction of the voice prosthesis not linked to an intra-prosthetic leak
- Patients whose tracheal fistula is no longer opened, or justifying a new tracheoesophageal puncture
- Patients with a voice prosthesis of a diameter strictly greater than 20 French
Show all 14Show fewer
- Patients with voice prosthesis of strictly less than 6 mm or greater than 14 mm length
- Patient under anti-fungal treatment during the month prior to inclusion
- Adult protected patients
- Inability to complete the questionnaires
- Patients with an estimated life expectancy of less than 1 year
- Patients not affiliated to French National Health care insurance
- Patients under the protection of Justice
- Pregnant woman
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Chu Bordeaux
Bordeaux
CHU CAEN
Caen
Chu Gui de Chauliac
Montpellier
Chu Nantes
Nantes
Chu Nimes
Nîmes
Clcc Institut Curie
Paris
Hopital Bichat
Paris
Hopital Tenon
Paris
Chru de Poitiers
Poitiers
Chru Pontchaillou
Rennes
Hopital Hautepierre
Strasbourg
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy
About this study
The purpose of this study is to determine the cost-effectiveness of vocal rehabilitation with reinforced inter-tracheoesophageal voice prosthesis versus standard voice prosthesis in case of repeated intra-prosthetic leakage in total laryngectomy patients.
This is a one year medico-economic study involving patients carrying a standard voice prosthesis implant and having undergone 2 successive prosthesis replacements within 3 months of interval and/or requiring at least 4 changes in the last 12 months, for intraprosthetic leakage.
Eligible subjects will be randomized in 2 groups: reinforced prosthesis with silver coating and double valve (Dual Valve) or standard prosthesis (single unreinforced valve), of the same model as the prosthesis previously implanted in the patient.
Read the detailed description
Prosthetic voice rehabilitation is a widespread practice that allows the patient to resume phonation quickly after total laryngectomy/total pharyngolaryngectomy/total circular pharyngolaryngectomy.
When the longevity of the implant is abnormally short (less than 3 months), the multiplication of changes is likely to increase the risk of overall morbidity related to maintaining the functionality of the voice prosthesis and to alter the patient's quality of life.
Reinforced innovative prostheses, currently not supported by the French Social Security, delay the occurrence of intraprosthetic leakage compared to standard prostheses.
This study assesses the economic efficiency from a societal perspective and a one-year time horizon, from vocal rehabilitation with reinforced inter-tracheoesophageal prosthesis versus standard voice prosthesis in case of intra-tracheal leakage in total laryngectomy patients.
Patients are randomized in 2 arms. Arm A usual care with reinforced prosthesis, or arm B usual care with standard prosthesis. Each patient is followed during 12 months.
- Conditions
- Laryngectomy
- Being tested
- Reinforced prosthesis, Standard prosthesis
- Keywords
- phonatory prosthesis, voice rehabilitation, reinforced voice prosthesis, laryngectomy, total pharyngolaryngectomy, total circular pharyngolaryngectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinforced prosthesisDevice
Implementation of a reinforced prosthesis during a medical consultation or under local anesthesia, after removal of the former prosthesis, in case of intraprothetic leakage.
Standard prosthesisDevice
Implementation of a standard prosthesis during a medical consultation or under local anesthesia, after removal of the former prosthesis, in case of intraprothetic leakage.
| Study group | Role | What they receive |
|---|---|---|
| Reinforced prosthesis | Experimental | Implementation of a reinforced prosthesis with silver coating and double valve, whatever which type of prosthesis the patient previously had. Receives: Device: Reinforced prosthesis |
| Standard prosthesis | Active comparator | Implementation of a standard prosthesis (simple valve, not reinforced), similar to the prosthesis the patient previously had. Receives: Device: Standard prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Cost-Effectiveness Ratio (cost per avoided prosthesis change), based on a societal perspective, comparing the use of a reinforced voice prosthesis to the use of a standard prosthesis
Effectiveness will be measured by the mean of number of prosthesis changes in each arm. Costs will be measured by 1) Outpatient resource consumption collected in a declarative patient questionnaire and 2) Hospital care resources using the database of the Medicalised Information System Program of each recruiting site
Measured: 12 months
Secondary outcomes (17)
Incremental cost-utility ratio, based on a societal perspective, comparing the use of a reinforced voice prosthesis to the use of a standard one
Utility will be measured by Quality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D 5L) health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible.
Cost will be measured as described in the Primary Outome Measure
Measured: 12 months
Quality of life using Euroqol-5 Dimensions (EQ-5D) questionnaire
Score of EQ-5D 5L. health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible, each answer corresponds to a score ranging from 1 to 5.
Measured: Baseline, 3 months, 6 months, 9 months and 12 months and at each voice prosthesis replacement
Quality of life using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
Score of the QLQ-C30 questionnaire, including 30 questions assessing some aspects of the quality of life of cancer patients. The total score ranges from 0 to 100.
Measured: Baseline, at 3 months, 6 months, 9 months and 12 months
Quality of life using the Head and Neck Quality of Life Questionnaire (QLQ - H&N 35)
Score of the QLQ - H\&N 35, including 35 questions assessing other aspects of quality of life in patients with head and neck cancer. The total score ranges from 0 to 100
Measured: Baseline, 3 months, 6 months, 9 months and 12 months
Quality of voice
score of the Voice Handicap Index: 10 items assessing the patient's voice, with 5 possible answers per item ranking from "never" to "always". The total score ranges from 0 to 120
Measured: Baseline, 3 months, 6 months, 9 months and 12 months and at each voice prosthesis replacement
Quality of voice assessed by the patient
Voice quality assessed by the patient and by a patient's relative with a numeric scale ranging from 0 "worst possible voice" to 10 "best possible voice", before and after each voice prosthesis change
Measured: Baseline, 3 months, 6 months, 9 months and 12 months
Patient quality of voice assessed by the patient's relative
Voice quality assessed by the patient's relative if present at time of prosthesis replacement, with a numeric scale ranging from 0 "worst possible voice" to 10 "best possible voice", before and after each voice prosthesis change
Measured: Baseline, at 3 months, 6 months, 9 months and 12 months
Trips induced by voice prosthesis replacement
Number of trips made by the patient for his prosthesis replacement, declared by the patient
Measured: 12 months
Time spent out of home
Time spent by the patient out of home induced by voice prosthesis leaks, declared by the patient
Measured: 12 months
Feeding interruption
Number of days or hours during which the patient could not eat due to voice prosthesis leak, declared by the patient
Measured: 12 months
Interruption of oral communication
Number of days or hours during which the patient could not speak due to voice prosthesis leak, declared by the patient
Measured: 12 months
Frequency of voice prosthesis replacements
Number of voice prosthesis replacements
Measured: 12 months
Lifetime of voice prostheses
Date of voice prosthesis replacement
Measured: 12 months
Complications due to voice prosthesis
Number and type of complications due to voice prosthesis
Measured: 12 months
Patient's pain due to voice prosthesis replacement
Pain due to voice prosthesis replacement assessed by a numeric scale ranging from 0 "no pain" to 10 "worst pain", asked to the patient before and after each voice prosthesis change
Measured: at each prosthesis replacement, during the 12 months follow-up
Patient's dysphagia due to voice prosthesis replacement
Score of the Dysphagia Handicap Index 10 items assessing the patient's dysphagia, with 5 possible answers per item ranking from "never" to "always". Total score ranges from 0 to 120.
Measured: Baseline and at each prosthesis replacement
Annual net financial benefit of developping the use of reinforced prosthesis
Net financial benefit of the development of reinforced phonatory implants' compared to standard implants'use for patients treated with thyroid lobectomy and with repeated intraprosthetic dysfunction, through a Budget Impact Analysis (BIA) with a 5-years' time horizon and a National Health Insurance's perspective (NHI).
Methods: Financial consequences for the NHI of several scenarii of development of the reinforced phonatory implants' will be represented in a table, year by year and over 5 years, in terms of cost per scenario and in terms of cost difference between the scenarii (showing savings or additional costs generated by choosing to develop the reinforced phonatory implant).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start21 Jan 2020
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaryngectomyStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Malard, Md PhD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100954
- Sponsor's protocol ID
- RC19_0180
- Acronym
- PHRASAL
- Status last verified
- Jun 2023
- First submitted
- 19 Sep 2019
- Last updated
- 6 Jun 2023
- 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 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness Analysis of Vocal Rehabilitation With Strengthened Tracheoesophageal Voice Implant Prosthesis Versus Standard Voice Prosthesis in Case of Repeated Intra-prosthetic Leakage After Total Laryngectomy
- ClinicalTrials.gov ID
- NCT04100954
- Acronym / sponsor ID
- PHRASAL / RC19_0180
- Conditions
- Laryngectomy
- Keywords
- phonatory prosthesis, voice rehabilitation, reinforced voice prosthesis, laryngectomy, total pharyngolaryngectomy, total circular pharyngolaryngectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 24 Sep 2019 (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.
The purpose of this study is to determine the cost-effectiveness of vocal rehabilitation with reinforced inter-tracheoesophageal voice prosthesis versus standard voice prosthesis in case of repeated intra-prosthetic leakage in total laryngectomy patients.
This is a one year medico-economic study involving patients carrying a standard voice prosthesis implant and having undergone 2 successive prosthesis replacements within 3 months of interval and/or requiring at least 4 changes in the last 12 months, for intraprosthetic leakage.
Eligible subjects will be randomized in 2 groups: reinforced prosthesis with silver coating and double valve (Dual Valve) or standard prosthesis (single unreinforced valve), of the same model as the prosthesis previously implanted in the patient.
Detailed description
Prosthetic voice rehabilitation is a widespread practice that allows the patient to resume phonation quickly after total laryngectomy/total pharyngolaryngectomy/total circular pharyngolaryngectomy.
When the longevity of the implant is abnormally short (less than 3 months), the multiplication of changes is likely to increase the risk of overall morbidity related to maintaining the functionality of the voice prosthesis and to alter the patient's quality of life.
Reinforced innovative prostheses, currently not supported by the French Social Security, delay the occurrence of intraprosthetic leakage compared to standard prostheses.
This study assesses the economic efficiency from a societal perspective and a one-year time horizon, from vocal rehabilitation with reinforced inter-tracheoesophageal prosthesis versus standard voice prosthesis in case of intra-tracheal leakage in total laryngectomy patients.
Patients are randomized in 2 arms. Arm A usual care with reinforced prosthesis, or arm B usual care with standard prosthesis. Each patient is followed during 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reinforced prosthesis | Experimental | Device: Reinforced prosthesisImplementation of a reinforced prosthesis with silver coating and double valve, whatever which type of prosthesis the patient previously had. |
| Standard prosthesis | Active comparator | Device: Standard prosthesisImplementation of a standard prosthesis (simple valve, not reinforced), similar to the prosthesis the patient previously had. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient treated surgically by total laryngectomy or total pharyngolaryngectomy or total circular pharyngolaryngectomy and carrying a voice prosthesis for at least 12 months
- Patient carrying a standard voice prosthesis and having undergone 2 successive prosthesis replacements within 3 months of interval and/or requiring at least 4 changes in the last 12 months, for intraprosthetic leakage
- Patients carrying a voice prosthesis, irrespective of the mark/model, of diameters between 16 and 20 French, and of length between 6 and 14 mm.
- Prosthetic replacement available under local or general anaesthesia
- Patient with primary cancer remission status
Key exclusion criteria (14 listed)
- Patient with local, regional or metastatic tumor evolution
- Patient who has had a first voice prosthesis for less than 12 months.
- Patient with peri-prosthetic leakage
- Patient presenting a dysfunction of the voice prosthesis not linked to an intra-prosthetic leak
- Patients whose tracheal fistula is no longer opened, or justifying a new tracheoesophageal puncture
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 |
|---|---|---|
| Reinforced prosthesisImplementation of a reinforced prosthesis during a medical consultation or under local anesthesia, after removal of the former prosthesis, in case of intraprothetic leakage. | Device | Reinforced prosthesis |
| Standard prosthesisImplementation of a standard prosthesis during a medical consultation or under local anesthesia, after removal of the former prosthesis, in case of intraprothetic leakage. | Device | Standard prosthesis |
Primary outcome
Incremental Cost-Effectiveness Ratio (cost per avoided prosthesis change), based on a societal perspective, comparing the use of a reinforced voice prosthesis to the use of a standard prosthesis
Time frame: 12 months
Effectiveness will be measured by the mean of number of prosthesis changes in each arm. Costs will be measured by 1) Outpatient resource consumption collected in a declarative patient questionnaire and 2) Hospital care resources using the database of the Medicalised Information System Program of each recruiting site
17 secondary outcomes
Incremental cost-utility ratio, based on a societal perspective, comparing the use of a reinforced voice prosthesis to the use of a standard one
Time frame: 12 months
Quality of life using Euroqol-5 Dimensions (EQ-5D) questionnaire
Time frame: Baseline, 3 months, 6 months, 9 months and 12 months and at each voice prosthesis replacement
Quality of life using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
Time frame: Baseline, at 3 months, 6 months, 9 months and 12 months
Quality of life using the Head and Neck Quality of Life Questionnaire (QLQ - H&N 35)
Time frame: Baseline, 3 months, 6 months, 9 months and 12 months
Quality of voice
Time frame: Baseline, 3 months, 6 months, 9 months and 12 months and at each voice prosthesis replacement
Quality of voice assessed by the patient
Time frame: Baseline, 3 months, 6 months, 9 months and 12 months
Patient quality of voice assessed by the patient's relative
Time frame: Baseline, at 3 months, 6 months, 9 months and 12 months
Trips induced by voice prosthesis replacement
Time frame: 12 months
Time spent out of home
Time frame: 12 months
Feeding interruption
Time frame: 12 months
Interruption of oral communication
Time frame: 12 months
Frequency of voice prosthesis replacements
Time frame: 12 months
Lifetime of voice prostheses
Time frame: 12 months
Complications due to voice prosthesis
Time frame: 12 months
Patient's pain due to voice prosthesis replacement
Time frame: at each prosthesis replacement, during the 12 months follow-up
Patient's dysphagia due to voice prosthesis replacement
Time frame: Baseline and at each prosthesis replacement
Annual net financial benefit of developping the use of reinforced prosthesis
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
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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.
Olivier Malard, Md PhD principal investigator
Nantes University Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reinforced prosthesis and Standard prosthesis in people with Laryngectomy, run by Nantes University Hospital at 13 sites in France.
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 14 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: status not confirmed, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. 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?
Results are not available in the source record.
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?
Incremental Cost-Effectiveness Ratio (cost per avoided prosthesis change), based on a societal perspective, comparing the use of a reinforced voice prosthesis to the use of a standard prosthesis (time frame: 12 months). 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 Jun 2023.