Clinical trial NCT06078527: Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort
Official title: Assessment of Laryngopharyngeal Sensation in Patients With Laryngopharyngeal Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Spasmodic Dysphonia Association
First posted: 2023-10-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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).

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).

Primary outcomes:
measure: Percentage of participants with triggered/positive laryngeal adduction response (LAR)
timeFrame: 1 day
measure: Median scores on the Penetration-Aspiration Scale (PAS)
timeFrame: 1 day
Secondary outcomes:
measure: Median scores on the participant-reported laryngeal sensation (PRLS)
timeFrame: 1 day
measure: Percentage of participants with visualized laryngopharyngeal responses
timeFrame: 1 day
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Yue Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: