Clinical Impact of Respiratory-Swallow Training on Refractory Dysphagia in Oropharyngeal Head and Neck Cancer

Head and neck cancer (HNC) is a significant health issue in Veterans. In fact, Veterans have
up to a two-fold increase in the incidence of HNC when compared to the general population.
Further, they often suffer profound functional deficits associated with surgical ablation and
toxicity from medical treatments used to cure or control local disease. Dysphagia (swallowing
impairment) is common after such treatments, particularly in oropharyngeal head and neck
cancer (OP HNC), and has life-altering consequences [on health, quality-of-life, the ability
to eat and drink normally, cost, and burden of care]. Despite important advancements in
medical and surgical treatments that prolong survival, many Veterans with HNC, particularly
those with OP HNC, are faced with chronic, intractable dysphagia resulting in persistent
drastic alterations in diet, the need for feeding tubes, and increased risk for aspiration
pneumonia - a life threatening infection. The investigators must devote research and clinical
efforts to mitigate these devastating impairments because the investigators' current
rehabilitative intervention options are severely limited. As such, and in keeping with the
VHA's Blueprint for Excellence Transformative Actions, the need for the development of
effective swallowing interventions that show potential for rapid translation to clinical
practice is imperative.

Coordination of respiration and swallowing is an essential element of airway protection
during swallowing and facilitates many critical aspects of swallowing physiology. This key,
coordinative event is significantly disrupted in patients with dysphagia following medical
and surgical treatments for OP HNC. The investigators' previous trial in patients with severe
and resistant dysphagia after cancer treatment and traditional swallowing therapy showed that
targeting and recalibrating respiratory-swallow phase patterning directly through an
innovative respiratory-swallow training (RST) method significantly improved aspects of
swallowing physiology crucial for airway protection and clearance of ingested materials
through the pharynx. These exciting new results led us to consider an expanded study with
refined methods and a home practice (HP) component that will extend beyond physiologic
efficacy and include more rigorous assessments of the clinical impact of RST. As with the
investigators' preliminary trial, the investigators' prediction is that these innovative
intervention methods will not only improve swallowing physiology and quality-of-life, but
will also result in significant functional improvements in every day eating and drinking in
Veterans with chronic, severe dysphagia that has been otherwise refractory to traditional
swallowing intervention(s). The benefit of RST training is that it is a simple,
straightforward method for patients to easily learn, and, when combined with the HP program,
it is designed to facilitate patient compliance and maintenance of intervention effects. The
investigators are also using commercially available and simple to use recording and analysis
hardware and software that can easily be expanded to mobile technology for more widespread
application to the many thousands of patients with dysphagia consequent to HNC.

A total of 88 subjects will be recruited and randomly assigned 1:1 to either RST
(intervention arm) or no active treatment (control arm), which is considered standard of care
in this patient population. Data obtained will be used to evaluate clinical efficacy and
durability. Data obtained from [an additional 11] subjects randomized to RST + home practice
(HP) will be used to assess the feasibility of adjuvant HP program and to obtain preliminary
data on its added impact on efficacy and response durability. The primary efficacy endpoint
is Functional Oral Intake Scale level, and the secondary endpoint will be respiratory-swallow
phase patterning. The investigators will also elaborate on the impact of RST by detailing the
physiological, airway protective, and morphometric changes that occur. The investigators will
use reproducible, reliable, and validated metrics that include the Modified Barium Swallow
Impairment Profile, Penetration-Aspiration Scale, and Computational Analysis of Swallowing
Mechanics to distinguish the mechanistic effects of RST. Further, adherence to a novel HP
component using self-guided practice will be introduced and tested for feasibility and
contribution to the degree and durability of the RST intervention effect.

The goal of this current study is to extend the investigator's preliminary trial that yielded
compelling physiologic changes with potential to improve the impact and durability of RST on
clinical outcomes essential for eating, drinking, health, and quality-of-life. The
investigators' overarching goal is to provide two parallel tracks of knowledge generation: 1)
provide immediate clinical translation of experimental findings to improve the lives of
Veterans, and 2) drive model generation on fundamental mechanisms of motor coordination.
Basic knowledge will drive clinical application and vice-a-versa. As such, this is an ideal
experimental and clinical context that will fuel knowledge generation in this highly
significant area of science and clinical practice.

Inclusion Criteria:

- Veteran

- have undergone treatment for a primary diagnosis of OP HNC

- are 21 years of age

- 6 months post-OP HNC treatment

- 6 months post-traditional swallowing treatment with continued dysphagia

- are non-smokers

- English speaking

- pass a cognitive screening (score 26 on the Montreal Cognitive Assessment (MoCA)

- do not present with severe chronic obstructive pulmonary disease (COPD) based on
pulmonary function testing (PFT)

- drink less than 2 alcoholic beverages per day

- have a Functional Oral Intake Scale (FOIS) level of 5 to ensure limitations in oral
intake (primary outcome measure)

Exclusion Criteria:

- if they have known allergy or dietary restriction for contrast materials or liquids
used during the MBSS or training

- currently smoking

- currently drinking greater than two drinks per day

- severe COPD

- are unable to swallow one liquid consistency without the use of a compensatory
strategy or swallow maneuver without aspiration

- history of aspiration pneumonia within the past 12 months