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Trial Title:
Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort
NCT ID:
NCT06078527
Condition:
Presbylarynx
Aspiration
Spasmodic Dysphonia
Globus Pharyngeus
Larynx Paralysis
Laryngeal Disease
Vocal Cord Paralysis
Iatrogenic Injury
Sensory Neuropathy
Conditions: Official terms:
Dysphonia
Vocal Cord Paralysis
Laryngeal Diseases
Paralysis
Globus Sensation
Conditions: Keywords:
Cancer survivors
Previous cancer treatment
Laryngopharyngeal disorders
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Device Feasibility
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Cheung-Bearelly Aesthesiometer
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.
Arm group label:
Cancer Survivors
Other name:
Aesthesiometer
Intervention type:
Procedure
Intervention name:
Transnasal Laryngoscopy
Description:
A procedure to examine your larynx (voice box)
Arm group label:
Cancer Survivors
Other name:
Transnasal Flexible Laryngoscopy
Intervention type:
Other
Intervention name:
Questionnaires
Description:
Patient-reported health and behavioral outcomes measures will be administered
Arm group label:
Cancer Survivors
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age <=18 years.
2. 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
3. Ability and willingness to comply with study procedures.
4. Ability to understand a written informed consent document, and the willingness to
sign it.
Exclusion Criteria:
1. Non-English speaking.
2. Laryngopharyngeal structures are not accessible on exam.
3. Known contraindication to any study-related procedure, or history of being unable to
tolerate laryngoscopy.
4. Vocal fold immobility or severe hypomobility on adduction.
5. 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Contact:
Last name:
Yue Ma
Phone:
877-827-3222
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Yue Ma, MD
Email:
Principal Investigator
Start date:
February 1, 2025
Completion date:
September 30, 2026
Lead sponsor:
Agency:
University of California, San Francisco
Agency class:
Other
Collaborator:
Agency:
National Spasmodic Dysphonia Association
Agency class:
Other
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06078527
