Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2023
CompletedFirst Posted
Study publicly available on registry
October 12, 2023
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
July 23, 2025
July 1, 2025
2.3 years
October 5, 2023
July 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
1 day
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.
1 day
Secondary Outcomes (2)
Median scores on the participant-reported laryngeal sensation (PRLS)
1 day
Percentage of participants with visualized laryngopharyngeal responses
1 day
Study Arms (1)
Cancer Survivors
EXPERIMENTALParticipants 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.
Interventions
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.
A procedure to examine your larynx (voice box)
Patient-reported health and behavioral outcomes measures will be administered
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yue Ma, MD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2023
First Posted
October 12, 2023
Study Start
October 1, 2025
Primary Completion (Estimated)
January 31, 2028
Study Completion (Estimated)
January 31, 2028
Last Updated
July 23, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share