Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort

NCT ID: NCT06078527

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-01-31

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).

Conditions

Presbylarynx; Aspiration; Spasmodic Dysphonia; Globus Pharyngeus; Larynx Paralysis; Laryngeal Disease; Vocal Cord Paralysis; Iatrogenic Injury; Sensory Neuropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Cancer Survivors

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.

Group Type: EXPERIMENTAL

Cheung-Bearelly Aesthesiometer

Intervention Type: DEVICE

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.

Transnasal Laryngoscopy

Intervention Type: PROCEDURE

A procedure to examine your larynx (voice box)

Questionnaires

Intervention Type: OTHER

Patient-reported health and behavioral outcomes measures will be administered

Interventions

Cheung-Bearelly Aesthesiometer

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: DEVICE

Transnasal Laryngoscopy

A procedure to examine your larynx (voice box)

Intervention Type: PROCEDURE

Questionnaires

Patient-reported health and behavioral outcomes measures will be administered

Intervention Type: OTHER

Other Intervention Names

Aesthesiometer; Transnasal Flexible Laryngoscopy

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Spasmodic Dysphonia Association

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yue Ma, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Central Contacts

Yue Ma, MD

Role: CONTACT

cancertrials@ucsf.edu

877-827-3222

Facility Contacts

Yue Ma

Role: primary

cancertrials@ucsf.edu

877-827-3222

Other Identifiers

NCI-2023-10667

Identifier Type: REGISTRY

Identifier Source: secondary_id

232011

Identifier Type: -

Identifier Source: org_study_id