Long Term Effects of Heat and Moisture Exchangers (HMEs)

Long Term Effects of Heat and Moisture Exchangers (HMEs) (Provox® Life™) on Pulmonary Symptoms in Laryngectomized Patients

Assessment of long term effect of Provox Life HME use on pulmonary symptoms in laryngectomized patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Laryngectomy; Status
• Intervention / Treatment: Device: Provox Life

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rafael De Cicco; Phone Number: +55 11 999649920; Email: rafaelcicco@doutorarnaldo.org

Study Locations

• Brazil
  • São Paulo, Brazil
    • Instituto de Cancer Dr. Arnaldo
    • Contact: Rafael De Cicco; Phone Number: +5511999649920; Email: rafaelcicco@doutorarnaldo.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Total laryngectomy, irrespective of pharynx reconstruction method
• 18 years or older
• Longer than 3 months after total laryngectomy
• Longer than 6 weeks after postoperative radiotherapy

Exclusion Criteria:

• Current use of HMEs (within last 3 months)
• Medical problems prohibiting the use of HME
• Active recurrent or metastatic disease (medical deterioration)
• Recent pulmonary infections/unstable pulmonary condition
• Insufficient physical, cognitive, or mental ability required to attach, remove or operate the devices themselves
• Low tidal volumes
• Unable to understand the Participant Information and/or unable to give Informed Consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Provox Life HME; Use of Provox Life HMEs and attachment	Device: Provox Life; Compliant use of Provox Life HMEs
No Intervention: Control - No HME; Control group is current standard of Care in Brazil, which is not using an HME

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CASA-Q Score	assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q). Score between 0 and 100, with higher scores meaning less symptoms and less impact.	Baseline, 3 months, 6 months, 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of involuntary coughs per 24 hours	Patient reported, recorded by tally sheeting	Baseline, 3 months, 6 months, 9 months
Forced Expectoration	Patient reported, recorded by tally sheeting	Baseline, 3 months, 6 months, 9 months
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, 3 months, 6 months, 9 months
Jenkins sleep evaluation questionnaire	Patient reported to assess sleep quality. Score between 0 and 20, with higher score the more sleep disturbances	Baseline, 3 months, 6 months, 9 months
Questionnaire to assess Shortness of Breath	from Ackerstaff et al., 1993	Baseline, 3 months, 6 months, 9 months
Voice handicap Index	patient reported outcome, score from 0-40, with higher scores indicating greater voice-related handicap.	Baseline, 3 months, 6 months, 9 months
Consumption of medical devices (Number of devices used)	Number of devices used, by use of patient diary recoding number of devices used	Baseline, 3 months, 6 months, 9 months
Study-specific questionnaire to assess number of complications and medical treatments	Study specific questionnaire to record complications and consumption of medications, diagnostics, treatment, medical care, medical transportation, sick leave	Baseline, 3 months, 6 months, 9 months

Collaborators and Investigators

• Sponsor: Atos Medical AB
• Collaborators: Instituto de Cancer Dr Arnaldo

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Pulmonary rehabilitation; Laryngectomy; HME; Heat and Moisture Exchanger
• Other Study ID Numbers: PL_Brazil

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