NCT06084611

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

March 26, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

1.5 years

First QC Date

October 10, 2023

Last Update Submit

September 30, 2025

Conditions

Laryngectomy; Status

Keywords

LaryngectomyHeat and Moisture ExchangerHMEPulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Number of involuntary coughs per 24 hours

    Baseline, 3 months, 6 months, 9 months

  • Forced Expectoration

    Baseline, 3 months, 6 months, 9 months

  • Quality of Life by EQ-5D-5L

    Baseline, 3 months, 6 months, 9 months

  • Jenkins sleep evaluation questionnaire

    Baseline, 3 months, 6 months, 9 months

  • Questionnaire to assess Shortness of Breath

    Baseline, 3 months, 6 months, 9 months

  • +3 more secondary outcomes

Study Arms (2)

Provox Life HME

EXPERIMENTAL

Use of Provox Life HMEs and attachment

Device: Provox Life

Control - No HME

NO INTERVENTION

Control group is current standard of Care in Brazil, which is not using an HME

Interventions

Provox LifeDEVICE

Compliant use of Provox Life HMEs

Provox Life HME

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Cancer Dr. Arnaldo

São Paulo, Brazil

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 16, 2023

Study Start

March 26, 2024

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)