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Assessment of (Chemo)RT-related Dysphagia in HNC Patients Based on Cough-related Acoustic Features

Primary Purpose

Head and Neck Cancer, Dysphagia

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Acoustic cough features analysis
Sponsored by
Jules Bordet Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: HNC patients in complete clinical remission (10 male/10 female adults & 10 male/10 female elderly) Patients diagnosed with dysphagia (with evaluation by videofluoroscopy) Patients treated with radiochemotherapy and selected three months after the end of treatment. Exclusion criteria: -pulmonary diseases.

Sites / Locations

  • Institut Jules BordetRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cough and voice analysis in HNC patients

Arm Description

Patients will undergo acoustic cough features analysis.

Outcomes

Primary Outcome Measures

acoustic cough features in HNC patients as biomarkers for dysphagia/aspiration.
cough and voice analysis (using voice recording and frequencies obtained) of HNC patients post RT will be analysed to detect early diagnosis biomarkers for dysphagia/aspiration

Secondary Outcome Measures

Full Information

First Posted
April 17, 2023
Last Updated
May 9, 2023
Sponsor
Jules Bordet Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05865756
Brief Title
Assessment of (Chemo)RT-related Dysphagia in HNC Patients Based on Cough-related Acoustic Features
Official Title
Assessment of Radio(Chemo)Therapy-related Dysphagia in Head and Neck Cancer Patients Based on Cough-related Acoustic Features
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jules Bordet Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To develop this objective and easily implementable assessment method of coughing based on acoustic features of voluntary and reflex coughs, there is a primary need in identifying and comparing acoustic cough features in healthy subjects and different disease-related coughs features. Cough is a common reason for seeking medical care. Chronic cough, defined as a cough that has lasted for longer that eight weeks, represents 10-38% of all referrals made to respiratory physicians [1-2]. Furthermore, between 60 and 80% of patients with chronic obstructivepulmonary disease (COPD) report cough. Following this pilot study comparing different populations, the applicability of the selected acoustic cough features should be examined in HNC patients with radiotherapy-induced dysphagia, Another frequent aspect of the clinical diagnostic examination of swallowing is perceptual analysis of voice quality immediately following deglutition. Changes in voice quality are assumed to provide information on the possible accumulation of saliva or food at the vocal folds level. It is reported that a change of voice may indicate laryngeal dysfunction or the presence of a foreign body at the laryngeal level [3] confirm that a normophonic voice after swallowing reflects a lack of aspiration-penetration. However, research shows that there is no strong correlation between aspiration and changes in perceptual voice quality (e.g. wet voice). A more reliable and easily implementable method could be detection of specific acoustic features of changes in voice quality.
Detailed Description
The ultimate goal of this study is to develop an innovative and non-invasive assessment method for dysphagia and aspiration in head and neck cancer (HNC) patients using acoustic features related to voluntary and/or reflex cough as biomarkers of dysphagia and/or aspiration in this population. Additionally, the relationship between acoustic features and aerodynamic cough and acoustic voice parameters will be investigated, extending our insight in pathophysiology of dysphagia in this population. To the investigators knowledge, no acoustic features of coughing and throat clearing in the frame of dysphagia have ever been explored. Regarding voice quality abnormalities, no acoustic parameters of reasonable evidence of dysphagia have been found.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Dysphagia

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
40HNC patients in complete clinical remission (10 male/10 female adults & 10 male/10 female elderly) diagnosed with dysphagia treated with radiochemotherapy and selected three months after the end of treatment will be submitted to cough and voice analysis.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cough and voice analysis in HNC patients
Arm Type
Other
Arm Description
Patients will undergo acoustic cough features analysis.
Intervention Type
Other
Intervention Name(s)
Acoustic cough features analysis
Intervention Description
Acoustic cough features analysis
Primary Outcome Measure Information:
Title
acoustic cough features in HNC patients as biomarkers for dysphagia/aspiration.
Description
cough and voice analysis (using voice recording and frequencies obtained) of HNC patients post RT will be analysed to detect early diagnosis biomarkers for dysphagia/aspiration
Time Frame
at least 3 months post-RT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: HNC patients in complete clinical remission (10 male/10 female adults & 10 male/10 female elderly) Patients diagnosed with dysphagia (with evaluation by videofluoroscopy) Patients treated with radiochemotherapy and selected three months after the end of treatment. Exclusion criteria: -pulmonary diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clémence Al Wardi, PhD
Phone
0032 2 541 39 81
Email
clemence.alwardi@bordet.be
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofiana Mootassim-Billah, Ms

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2178528
Citation
Irwin RS, Curley FJ, French CL. Chronic cough. The spectrum and frequency of causes, key components of the diagnostic evaluation, and outcome of specific therapy. Am Rev Respir Dis. 1990 Mar;141(3):640-7. doi: 10.1164/ajrccm/141.3.640.
Results Reference
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PubMed Identifier
10319055
Citation
McGarvey LP, Heaney LG, Lawson JT, Johnston BT, Scally CM, Ennis M, Shepherd DR, MacMahon J. Evaluation and outcome of patients with chronic non-productive cough using a comprehensive diagnostic protocol. Thorax. 1998 Sep;53(9):738-43. doi: 10.1136/thx.53.9.738.
Results Reference
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PubMed Identifier
20454806
Citation
Waito A, Bailey GL, Molfenter SM, Zoratto DC, Steele CM. Voice-quality abnormalities as a sign of dysphagia: validation against acoustic and videofluoroscopic data. Dysphagia. 2011 Jun;26(2):125-34. doi: 10.1007/s00455-010-9282-4. Epub 2010 May 8.
Results Reference
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Assessment of (Chemo)RT-related Dysphagia in HNC Patients Based on Cough-related Acoustic Features

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