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, 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, 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 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 50 participants will be recruited with the goal of 40 participants enrolled. Participants will be randomly assigned 1:1 to either immediate RST (intervention arm) or delayed RST (control arm). The participants in the control arm will have no active treatment for 4 weeks and will then participate in RST as a cross-over design. Data obtained will be used to evaluate clinical efficacy and durability The primary efficacy endpoint is physiologic function metrics of the oropharyngeal swallow, and the secondary endpoints are airway invasion and patient reported outcomes. We will use reproducible, reliable, and validated metrics that include the Modified Barium Swallow Impairment Profile and Penetration-Aspiration Scale to distinguish the mechanistic effects of RST.
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.
