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Completed

NCT Number: NCT04974801

Assessment of the New Provox Life System for Pulmonary Health 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.

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Key information

Conditions

Laryngectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Roma, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Provox Life

Device

Use of Provox Life range of HMEs for different situations and their attachments (adhesives and laryngectomy tubes)

Usual Care

Device

Continued Usual Care routines.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

Sponsors and collaborators

Lead sponsor

Atos Medical AB

Industry

Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 23, 2021
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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