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Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort

a study on Presbylarynx Aspiration Spasmodic Dysphonia Globus Pharyngeus Larynx Paralysis Laryngeal Disease Vocal Cord Paralysis Iatrogenic Injury Neuropathy

Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Yue Ma, MD
Headshot of Yue Ma
Yue Ma

Description

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.

Official Title

Assessment of Laryngopharyngeal Sensation in Patients With Laryngopharyngeal Disorders

Details

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to:
  2. modified barium swallow (MBS) study kinematics;
  3. MBS Dynamic Imaging Grade of Swallowing Toxicity (MBS DIGEST);
  4. MD Anderson Dysphagia Inventory patient reported outcomes measure (MDADI PROMs);
  5. Dynamic Imaging Grade of Swallowing Toxicity for Flexible Endoscopic Evaluation of Swallowing (DIGEST-FEES)
  6. 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).

Keywords

Presbylarynx, Aspiration, Spasmodic Dysphonia, Globus Pharyngeus, Larynx Paralysis, Laryngeal Disease, Vocal Cord Paralysis, Iatrogenic Injury, Sensory Neuropathy, Cancer survivors, Previous cancer treatment, Laryngopharyngeal disorders, Dysphonia, Laryngeal Diseases, Paralysis, Globus Sensation, Cheung-Bearelly Aesthesiometer, Transnasal Laryngoscopy

Eligibility

You can join if…

Open to people ages 18-85

  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.

You CAN'T join if...

  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).

Location

  • UCSF
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Yue Ma, MD
    Dr. Ma is an Assistant Clinical Professor in the UCSF Department of Otolaryngology – Head and Neck Surgery. She received her medical degree from the University of Arizona College of Medicine where she was elected to the Alpha Omega Alpha Honor Medical Society and Gold Humanism Honorary Society.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06078527
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated