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Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort

Primary Purpose

Presbylarynx, Aspiration, Spasmodic Dysphonia

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cheung-Bearelly Aesthesiometer
Transnasal Laryngoscopy
Questionnaires
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Presbylarynx focused on measuring Cancer survivors, Previous cancer treatment, Laryngopharyngeal disorders

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age <=18 years. Individuals without a laryngopharyngeal disorder (health controls) or with a laryngopharyngeal disorder. Laryngopharyngeal disorder includes but is not limited to: presbylarynx, aspiration; spasmodic dysphonia; globus pharynges; vocal fold paralysis; iatrogenic injury to the larynx; muscle tension dysphonia; neurogenic dysphagia; laryngeal sensory neuropathy; and laryngopharyngeal disorders resulting from prior radiation therapy in individuals with a history of head and neck cancer who have completed radiation therapy as primary or adjuvant cancer treatment Ability and willingness to comply with study procedures. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: Non-English speaking. Laryngopharyngeal structures are not accessible on exam. Known contraindication to any study-related procedure, or history of being unable to tolerate laryngoscopy. Vocal fold immobility or severe hypomobility on adduction. For head and neck cancer survivors only: Currently undergoing radiation therapy for head and neck cancer (i.e., primary/adjuvant radiation therapy treatment plan is not yet completed).

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cancer Survivors

Arm Description

Participants will attend a single 15-30 minute study session during which they will answer questionnaires (5-10 minutes) and undergo laryngopharyngeal sensory testing (10-20 minutes). There will be up to 2 years of medical record follow up after completing the main study.

Outcomes

Primary Outcome Measures

Percentage of participants with triggered/positive laryngeal adduction response (LAR)
Elicitation of LAR is defined as a unilateral or bilateral laryngeal adduction immediately following laryngeal stimulus through frame-by-frame analysis of video recordings (visualized on laryngoscopy). An acceptable tactile stimulus is near orthogonal (less than 30 degrees deviation) to the mucosal surface and unobstructed by salivary forces. The percentage of participants with LAR will be reported
Median scores on the Penetration-Aspiration Scale (PAS)
The PAS is a widely-used ordinal scale metric used to describe severity of aspiration. The PAS score is multidimensional, i.e., include several observations within each score: (1) depth of airway invasion (material above, contacting, or below the level of vocal folds; (2) whether or not there is material remaining after the swallow (ejected, not ejected); and (3) the patient's response to material present in the airway (effort to clear the material). The PAS is an 8-point ordinal scale, with a total score ranging from 1 representing the least and 8 representing the highest or most severe score.

Secondary Outcome Measures

Median scores on the participant-reported laryngeal sensation (PRLS)
The PRLS is defined as a binary response to participants' self-reported detection of laryngeal stimulation. Once the participant indicates they perceived the stimulus, the research team will ask the participant to provide a perceptual strength rating on a 1-10 scale, with higher scores indicated a greater strength of stimulus.
Percentage of participants with visualized laryngopharyngeal responses
Percentage of participants with visualized laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus will be recorded by the clinician and reported.

Full Information

First Posted
October 5, 2023
Last Updated
October 5, 2023
Sponsor
University of California, San Francisco
Collaborators
National Spasmodic Dysphonia Association
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1. Study Identification

Unique Protocol Identification Number
NCT06078527
Brief Title
Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort
Official Title
Assessment of Laryngopharyngeal Sensation in Patients With Laryngopharyngeal Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Spasmodic Dysphonia Association

4. Oversight

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

5. Study Description

Brief Summary
A previous study completed in 2022 (NCT05158179) was conducted using cohorts of healthy controls, and adults with general laryngopharyngeal disorders. This study will expand on the previous research to include a separate cohort of adults being seen in clinic for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments.
Detailed Description
PRIMARY OBJECTIVES: I. Laryngeal sensation as measured by elicitation of laryngeal adductor reflex (LAR). II. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to the Penetration-Aspiration Scale (PAS). SECONDARY OBJECTIVES: I. To assess patient-reported laryngeal sensation (PRLS) following stimulus and perceptual strength. II. To assess laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus. III. To assess patient reported outcomes (PROs). EXPLORATORY OBJECTIVES: I. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to: modified barium swallow (MBS) study kinematics; MBS Dynamic Imaging Grade of Swallowing Toxicity (MBS DIGEST); MD Anderson Dysphagia Inventory patient reported outcomes measure (MDADI PROMs); Dynamic Imaging Grade of Swallowing Toxicity for Flexible Endoscopic Evaluation of Swallowing (DIGEST-FEES) Flexible Endoscopic Evaluation of Swallowing Visual Analysis of Swallowing Efficiency and Safety (FEES VASES). OUTLINE: Participants receiving care at University of California, San Francisco (UCSF) for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments will undergo laryngopharyngeal sensory testing at a single visit. There will be up to 2 years of medical record follow up after completing the main study. Data collected from this separate cohort may be compared with historical data collected in a previous study (NCT05158179).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbylarynx, Aspiration, Spasmodic Dysphonia, Globus Pharyngeus, Larynx Paralysis, Laryngeal Disease, Vocal Cord Paralysis, Iatrogenic Injury, Sensory Neuropathy
Keywords
Cancer survivors, Previous cancer treatment, Laryngopharyngeal disorders

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cancer Survivors
Arm Type
Experimental
Arm Description
Participants will attend a single 15-30 minute study session during which they will answer questionnaires (5-10 minutes) and undergo laryngopharyngeal sensory testing (10-20 minutes). There will be up to 2 years of medical record follow up after completing the main study.
Intervention Type
Device
Intervention Name(s)
Cheung-Bearelly Aesthesiometer
Other Intervention Name(s)
Aesthesiometer
Intervention Description
The Cheung-Bearelly Aesthesiometer will be used to deliver a range of calibrated stimuli through the channeled flexible laryngoscope to assess sensation of the laryngopharynx.
Intervention Type
Procedure
Intervention Name(s)
Transnasal Laryngoscopy
Other Intervention Name(s)
Transnasal Flexible Laryngoscopy
Intervention Description
A procedure to examine your larynx (voice box)
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Patient-reported health and behavioral outcomes measures will be administered
Primary Outcome Measure Information:
Title
Percentage of participants with triggered/positive laryngeal adduction response (LAR)
Description
Elicitation of LAR is defined as a unilateral or bilateral laryngeal adduction immediately following laryngeal stimulus through frame-by-frame analysis of video recordings (visualized on laryngoscopy). An acceptable tactile stimulus is near orthogonal (less than 30 degrees deviation) to the mucosal surface and unobstructed by salivary forces. The percentage of participants with LAR will be reported
Time Frame
1 day
Title
Median scores on the Penetration-Aspiration Scale (PAS)
Description
The PAS is a widely-used ordinal scale metric used to describe severity of aspiration. The PAS score is multidimensional, i.e., include several observations within each score: (1) depth of airway invasion (material above, contacting, or below the level of vocal folds; (2) whether or not there is material remaining after the swallow (ejected, not ejected); and (3) the patient's response to material present in the airway (effort to clear the material). The PAS is an 8-point ordinal scale, with a total score ranging from 1 representing the least and 8 representing the highest or most severe score.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Median scores on the participant-reported laryngeal sensation (PRLS)
Description
The PRLS is defined as a binary response to participants' self-reported detection of laryngeal stimulation. Once the participant indicates they perceived the stimulus, the research team will ask the participant to provide a perceptual strength rating on a 1-10 scale, with higher scores indicated a greater strength of stimulus.
Time Frame
1 day
Title
Percentage of participants with visualized laryngopharyngeal responses
Description
Percentage of participants with visualized laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus will be recorded by the clinician and reported.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age <=18 years. Individuals without a laryngopharyngeal disorder (health controls) or with a laryngopharyngeal disorder. Laryngopharyngeal disorder includes but is not limited to: presbylarynx, aspiration; spasmodic dysphonia; globus pharynges; vocal fold paralysis; iatrogenic injury to the larynx; muscle tension dysphonia; neurogenic dysphagia; laryngeal sensory neuropathy; and laryngopharyngeal disorders resulting from prior radiation therapy in individuals with a history of head and neck cancer who have completed radiation therapy as primary or adjuvant cancer treatment Ability and willingness to comply with study procedures. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: Non-English speaking. Laryngopharyngeal structures are not accessible on exam. Known contraindication to any study-related procedure, or history of being unable to tolerate laryngoscopy. Vocal fold immobility or severe hypomobility on adduction. For head and neck cancer survivors only: Currently undergoing radiation therapy for head and neck cancer (i.e., primary/adjuvant radiation therapy treatment plan is not yet completed).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Lappin, Jr.
Phone
877-827-3222
Email
james.lappin@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yue Ma, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Lappin, Jr.
Phone
877-827-3222
Email
james.lappin@ucsf.edu
Email
cancertrials@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Yue Ma, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort

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