Training Swallowing Initiation During Expiration

Head and Neck Cancer Clinical Trial

Official title:

Training Swallowing Initiation During Expiration: Impact on Safety and Efficiency Following Treatment for Oropharyngeal Head and Neck Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05278039
• Other study ID #: R01CA262502
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2022
• Est. completion date: July 1, 2026

Study information

• Verified date: June 2024
• Source: Northwestern University
• Contact: Bonnie Martin-Harris, PhD
• Phone: 847-467-7447
• Email: scsc[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Head and Neck Cancer
• Head and Neck Neoplasms
• Oropharyngeal Dysphagia
• Oropharynx Squamous Cell Carcinoma

Intervention

Behavioral:
• Respiratory-Swallow Phase Training
Participants will complete 6 respiratory-swallow phase training sessions that will last approximately one hour.

Other:
• Swallow Practice
Participants will complete 6 "swallow practice" sessions that will last approximately one hour.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Northwestern University	Evanston	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Northwestern Memorial Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in M.D. Anderson Dysphagia Inventory (MDADI) scores	Evaluates the impact of dysphagia on the quality of life of patients with head and neck cancer	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.
Primary	Change in frequency (%) of swallows initiated during expiration	Determines percent (frequency) of the target (expiratory phase) for each swallow.	Change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment.
Primary	Change in Penetration-Aspiration Scale scores	Measures presence, depth and reaction to penetration and aspiration.	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	Change in Normalized Residue Ratio Scale scores	Quantifies pharyngeal space residue obtained in the lateral view during Modified Barium Swallow Study (MBSS)	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.
Secondary	Change in Modified Barium Swallow Impairment Profile (MBSImP) scores	Measures physiologic swallowing impairment from observations of MBSS recordings	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.