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

Laryngectomy Clinical Trial

Official title:

A Randomized Cross Over Clinical Trial Assessing the New Provox Life System for Pulmonary Rehabilitation and Quality of Life After Total Laryngectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04974801
• Other study ID #: Prot_Id_3523
• Status: Completed
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: April 21, 2021

Study information

• Verified date: March 2022
• Source: Atos Medical AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 21, 2021
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laryngectomy

Intervention

Device:
• Provox Life
Use of Provox Life range of HMEs for different situations and their attachments (adhesives and laryngectomy tubes)
• Usual Care
Continued Usual Care routines.

Locations

Country	Name	City	State
Italy	Universita Cattolica del Sacro Cuore di Roma, Faculty of Medicine and Surgery 'Agostino Gemelli'	Roma

Sponsors (2)

Lead Sponsor	Collaborator
Atos Medical AB	Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 Mar 22:1945998221086200. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average number of forced mucus expectorations per 24 hours	Patient reported, recorded by Tally sheeting on 3 days	during week 6 of period 1 and period 2 (each period is 6 weeks)
Secondary	Average number of (involuntary) dry coughs per 24 hours	Patient reported, recorded by Tally sheeting on 3 days	during week 6 of period 1 and period 2 (each period is 6 weeks)
Secondary	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.	Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks)
Secondary	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.	Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks)
Secondary	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.	Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks)
Secondary	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.	Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
Secondary	Peristomal skin irritation	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)
Secondary	Average number of days with skin irritation	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)
Secondary	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	Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
Secondary	Frequency of using sleeping medication	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)
Secondary	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	during week 5 and week 6 of period 1 and period 2 (each period is 6 weeks)
Secondary	Situational usage pattern of Provox Life HMEs	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)
Secondary	Patient satisfaction with the Provox Life devices	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)