Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06078527
Study type	Interventional
Source	University of California, San Francisco
Contact	James Lappin, Jr.
Phone	877-827-3222
Email	james.lappin@ucsf.edu
Status	Not yet recruiting
Phase	N/A
Start date	April 30, 2024
Completion date	January 31, 2026

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04083677` - Routine Point of Care Ultrasound (POCUS) Assessment of Antral Gastric Contents in Traumatic Surgical Patients for Prevention of Aspiration Pneumonitis
Terminated	`NCT05101668` - Safety and Efficacy of Intracranial Thrombus Aspiration Catheter in the Treatment of Acute Large-vessel Occlusive Stroke	N/A
Completed	`NCT02588495` - Accuracy of Gastric Ultrasound to Diagnose a "Full Stomach". A Bayesian Framework	N/A
Completed	`NCT02576756` - Retrospective Study in Patients Who Have Had a Difficult Intubation.	N/A
Completed	`NCT01777672` - Effect of Afferent Oropharyngeal Pharmacological and Electrical Stimulation on Swallow Response and on Activation of Human Cortex in Stroke Patients With Oropharyngeal Dysphagia	Phase 2
Completed	`NCT05033041` - Gastric Volumes by US in Term Parturients Undergoing CS With and Without Metoclopramide	Phase 4
Recruiting	`NCT05079620` - Early Antibiotics After Aspiration in ICU Patients	Phase 4
Completed	`NCT01011803` - Correlation of Phonation With Deglutition and Aspiration Risk in the ICU Patients - an Exploratory Study	N/A
Recruiting	`NCT06137976` - Surgeon Perception of Gastric Decompression at Time of Gynecologic Laparoscopy	N/A
Completed	`NCT04645043` - Ultrasound Guided Esophageal Pressure	N/A
Completed	`NCT01807884` - Comparison of Two Strategies of Oropharyngeal and Tracheal Suctioning in Mechanically Ventilated Patients	N/A
Completed	`NCT03573609` - Evaluation of the Effectiveness and Safety of Supratube Device	N/A
Completed	`NCT03555604` - Evaluation of the Effect of Body Mass Index on Gastric Volume With Ultrasound in Term Pregnant Women
Enrolling by invitation	`NCT04411290` - Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases
Completed	`NCT05734937` - Ultrasound Evaluation of Gastric Volume in Pediatric Patients Undergoing Adenotonsillectomy Surgery	N/A
Recruiting	`NCT05330351` - Gastric Ultrasound in Pediatric Trauma Patients
Terminated	`NCT02437513` - NewBreez for Airway Protection in Head and Neck Cancer Patients With Chronic Aspiration	N/A
Completed	`NCT04786691` - How do You Take Your Coffee Before Anesthesia	N/A
Completed	`NCT05434442` - Caregivers Tracheal Aspiration Training	N/A
Completed	`NCT03305757` - Seroma Reduction After Mastectomy	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.