Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort

Официальное название

Assessment of Laryngopharyngeal Sensation in Patients With Laryngopharyngeal Disorders

Обзор

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.

Подробное описание

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).

Вмешательства

• Устройство 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.
• Процедура Transnasal Laryngoscopy
  A procedure to examine your larynx (voice box)
• Другое Questionnaires
  Patient-reported health and behavioral outcomes measures will be administered

Первичные конечные точки

• Percentage of participants with triggered/positive laryngeal adduction response (LAR) [Срок оценки: 1 day]
• Median scores on the Penetration-Aspiration Scale (PAS) [Срок оценки: 1 day]

Вторичные конечные точки (2)

• Median scores on the participant-reported laryngeal sensation (PRLS) [Срок оценки: 1 day]
• Percentage of participants with visualized laryngopharyngeal responses [Срок оценки: 1 day]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT06078527 · 232011 · NCI-2023-10667

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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