Assessment of the New Provox Life System for Pulmonary Health and Quality of Life After Total Laryngectomy

March 24, 2022 updated by: Atos Medical AB

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Universita Cattolica del Sacro Cuore di Roma, Faculty of Medicine and Surgery 'Agostino Gemelli'

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Provox Life HMEs followed by Usual Care HMEs
Use of Provox Life devices during a period of six weeks followed by use of Usual Care devices during a period of six weeks.
Device: Provox Life
Use of Provox Life range of HMEs for different situations and their attachments (adhesives and laryngectomy tubes)
Device: Usual Care
Continued Usual Care routines.
OTHER: Usual Care HMEs followed by Provox Life HMEs
Use of Usual Care devices during a period of six weeks followed by use of Provox Life devices during a period of six weeks.
Device: Provox Life
Use of Provox Life range of HMEs for different situations and their attachments (adhesives and laryngectomy tubes)
Device: Usual Care
Continued Usual Care routines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during week 6 of period 1 and period 2 (each period is 6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Patient reported, recorded by Tally sheeting on 3 days
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)
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.
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)
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.
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 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.
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)
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.
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)
Recorded by study specific questionnaire on frequency of Skin irritation.
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)
Patient reported, recorded by daily diary keeping the last two weeks of each study period
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)
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
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)
Study-specific questionnaire on use of sleeping medications
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)
Patient reported, recorded by daily diary keeping the last two weeks of each study period
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)
Study-specific questionnaire about the situational use of devices
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)
Patient satisfaction with devices through study specific questionnaires.
At the end of Period 1 (Group A), at the end of Period 2 (Group B) (each period is 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atos Medical AB

Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Claudio Parilla, Dr., Universita Cattolica del Sacro Cuore di Roma, Faculty of Medicine and Surgery 'Agostino Gemelli'

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 14, 2020

Primary Completion (ACTUAL)

April 21, 2021

Study Completion (ACTUAL)

April 21, 2021

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 16, 2021

First Posted (ACTUAL)

July 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2022

Last Update Submitted That Met QC Criteria

March 24, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Prot_Id_3523

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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