Clinical trial NCT04974801: Assessment of the New Provox Life System for Pulmonary Health and Quality of Life After Total Laryngectomy
Official title: A Randomized Cross Over Clinical Trial Assessing the New Provox Life System for Pulmonary Rehabilitation and Quality of Life After Total Laryngectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngectomy
Keywords: Pulmonary rehabilitation
Quality of Life
Heat and Moisture Exchangers
Lead sponsor: Atos Medical AB
Sponsor class: INDUSTRY
Collaborators: name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
First posted: 2021-07-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single center, randomized, prospective crossover study
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Average number of forced mucus expectorations per 24 hours
timeFrame: during week 6 of period 1 and period 2 (each period is 6 weeks)
Secondary outcomes:
measure: Average number of (involuntary) dry coughs per 24 hours
timeFrame: during week 6 of period 1 and period 2 (each period is 6 weeks)
measure: Coughing Symptoms (COUS) domain score of CASA-Q
timeFrame: Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks)
measure: Coughing Impact (COUI) domain score of CASA-Q
timeFrame: Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks)
measure: Sputum Symptoms (SPUS) domain score of CASA-Q
timeFrame: Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks)
measure: Sputum Impact (SPUI) domain score of CASA-Q
timeFrame: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
measure: Peristomal skin irritation
timeFrame: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
measure: Average number of days with skin irritation
timeFrame: during week 5 and week 6 of period 1 and period 2 (each period is 6 weeks)
measure: Quality of Life by EQ-5D-5L
timeFrame: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
measure: Frequency of using sleeping medication
timeFrame: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
measure: Average number of hours of HME use per 24 hours
timeFrame: during week 5 and week 6 of period 1 and period 2 (each period is 6 weeks)
measure: Situational usage pattern of Provox Life HMEs
timeFrame: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
measure: Patient satisfaction with the Provox Life devices
timeFrame: At the end of Period 1 (Group A), at the end of Period 2 (Group B) (each period is 6 weeks)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Universita Cattolica del Sacro Cuore di Roma, Faculty of Medicine and Surgery 'Agostino Gemelli'
Study officials:
affiliation: Universita Cattolica del Sacro Cuore di Roma, Faculty of Medicine and Surgery 'Agostino Gemelli'
name: Claudio Parilla, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.