Clinical trial NCT05278039: Training Swallowing Initiation During Expiration
Official title: Training Swallowing Initiation During Expiration: Impact on Safety and Efficiency Following Treatment for Oropharyngeal Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Dysphagia
Oropharyngeal Dysphagia
Oropharynx Squamous Cell Carcinoma
Keywords: Dysphagia
Swallowing Disorders
Swallowing Rehabilitation
Telehealth
Wearable Sensor
Respiratory-Swallow Coordination
Modified Barium Swallow Study
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Northwestern Memorial Hospital
First posted: 2022-03-14
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized-controlled trial
Primary purpose: TREATMENT

Brief summary: Head and neck cancers have escalated to epidemic levels in the United States, and survivors are suffering from life-long, devastating swallowing disorders with limited therapeutic options. This clinical trial investigates a novel swallowing treatment that trains initiation of swallowing during the expiratory phase of respiration to improve swallowing safety and efficiency.

Detailed description: Head and neck cancers (HNC) have increased to epidemic levels in the United States. Despite good response to cancer treatment, survivors are suffering life-long toxicities that result in swallowing problems (dysphagia). Treatment options for dysphagia after HNC are extremely limited, focus on swallowing movements alone, and do not consider the importance of respiratory-swallow phase patterning. Prior evidence has demonstrated that when aberrant respiratory-swallow phase patterning is present (initiation of swallowing during inspiration) in patients with HNC, there is a higher occurrence of swallowing impairments, increased residue, and airway invasion. Further, it has been well established that the expiratory limb of the respiratory cycle provides a biomechanically advantageous set point in which to initiate safe and efficient swallowing. This randomized, controlled, Phase II clinical trial examines if respiratory-swallow phase training improves airway protection and swallowing efficiency in HNC survivors who are three or more months post-completion of first-line cancer treatment. The primary goal (Aim 1) is to determine if respiratory-swallow phase training results in increased frequency (%) of swallows initiated during expiration and improved swallowing safety. The secondary goal (Aim 2) is to examine the impact of respiratory-swallow phase training on the frequency of swallows initiated during expiration in wakeful, naturalistic swallowing environments, including eating and drinking. The investigators will recruit 88 HNC survivors with dysphagia, impaired respiratory-swallow phase patterning, and airway compromise. The investigators will deliver therapy remotely using a telehealth platform and an innovative wearable sensor that provides real-time visual feedback of respiratory-swallow movements. Endpoints will be measured from synchronized videofluoroscopic and respiratory-swallow sensor recordings at baseline, within 1-week post-treatment, and 1-month and 3-months post-treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary head and neck cancer
* Three or more months post-completion of first-line cancer treatment
* English speaking
* Functional/corrected visual and hearing acuity
* No current alcohol or other drug abuse
* Without very severe (forced expiratory volume; FEV) 1 \<30% predicted) stage Chronic Obstructive Pulmonary Disease (COPD) based on Pulmonary Function Testing (PFT)
* No skin allergy to the medical-grade sensor adhesive
* Tolerate wearing the sensor for at least 10 hours/day
* Tolerate some liquid oral intake on a routine basis
* Normal dexterity to self-administer liquids via teaspoon
* Initiation of swallowing during inspiratory phase of respiration on ≥20% of swallows
* Penetration Aspiration Scale (PAS) score ≥3 or impairment on at least one MBSImP OI score (laryngeal vestibular closure ≥1, tongue base retraction ≥2, or pharyngeal residue ≥2) on at least one swallow during lateral view of MBSS
* A PAS score of ≤6 on at least one liquid consistency without the use of a compensatory strategy or swallow maneuver

Exclusion Criteria:

* Persistent or recurrent cancer at the time of enrollment
* Known allergy to contrast materials or liquids used during the MBSS or training
* Known allergy to sensor adhesive
* Unable to demonstrate competency with the user-friendly technology
* Diagnosis of neurological disorders
* Indwelling tracheostomy tube
* Nasogastric (NG) feeding tube
* History of aspiration pneumonia within the past 12 months
* Unable to self-administer liquid boluses
* Unable to swallow some liquids without a maneuver
* Likely or currently pregnant

Primary outcomes:
measure: Change in frequency (%) of swallows initiated during expiration
timeFrame: Change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment.
measure: Change in Penetration-Aspiration Scale scores
timeFrame: Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Scores range from 1-8 and higher scores indicate worse outcome.
Secondary outcomes:
measure: Change in Normalized Residue Ratio Scale scores
timeFrame: Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Scores range from 0 to 100% and higher scores indicate worse outcome.
measure: Change in Modified Barium Swallow Impairment Profile (MBSImP) scores
timeFrame: Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Oral Total scores range from 0-22 and Pharyngeal Total scores range from 0-26 and higher values indicate worse outcome.
Other outcomes:
measure: Change in M.D. Anderson Dysphagia Inventory (MDADI) scores
timeFrame: Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Scores range from 20 to 100 and higher scores indicate worse outcome.
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern Memorial Hospital
name: Bonnie Martin-Harris, PhD
role: PRINCIPAL_INVESTIGATOR
References: