Training swallowing initiation during expiration for head and neck cancer survivors
Training Swallowing Initiation During Expiration: Impact on Safety and Efficiency Following Treatment for Oropharyngeal Head and Neck Cancer
This study is testing a new way to help survivors of head and neck cancer improve their swallowing by teaching them to swallow while they breathe out.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05278039 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a novel approach to treating swallowing disorders in survivors of head and neck cancer by training them to initiate swallowing during the expiratory phase of respiration. The study aims to improve swallowing safety and efficiency, addressing the common issue of dysphagia that persists after cancer treatment. Participants will undergo respiratory-swallow phase training and swallow practice, with the effectiveness measured through randomized controlled methods. The trial focuses on individuals who are at least three months post-first-line cancer treatment and have specific swallowing impairments.
Who should consider this trial
Good fit: Ideal candidates for this study are English-speaking survivors of primary head and neck cancer who are three or more months post-completion of their first-line cancer treatment.
Not a fit: Patients with very severe chronic obstructive pulmonary disease (COPD) or those unable to tolerate wearing a sensor for the required duration may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance the quality of life for patients by improving their ability to swallow safely and efficiently.
How similar studies have performed: While this approach is innovative, prior studies have indicated that addressing respiratory-swallow phase patterning can lead to improved swallowing outcomes, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 1 other locations
- Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
- Northwestern University — Evanston, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Bonnie Martin-Harris, PhD — Northwestern Memorial Hospital
- Study coordinator: Bonnie Martin-Harris, PhD
- Email: scsc@northwestern.edu
- Phone: 847-467-7447
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.