Hines, Illinois 60141

  • Dysphagia

Purpose:

Veterans following treatment of head and neck cancer can be left with lasting swallowing impairment that may require diet alterations, need for feeding tubes, and risk of pneumonia. The investigators' previous trial tested a new swallowing treatment approach to target respiratory-swallow coordination. The results revealed improvements in respiratory-swallow coordination and swallowing function. The goal of this study is to determine the impact and durability of respiratory-swallow training (RST) on clinical outcomes necessary for eating, drinking, health, and quality-of-life in Veterans with swallowing impairment following treatment for head and neck cancer. A total of 88 participants will be recruited and randomly assigned to the RST or standard of care. An additional 11 participants will be recruited to RST plus a home practice portion to obtain preliminary data regarding efficacy of home practice.


Study summary:

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 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 physiologic function metrics of the oropharyngeal swallow. The investigators will also elaborate on the impact of RST by detailing the airway protective, oral intake status, and quality of life changes that occur. The investigators will use reproducible, reliable, and validated metrics that include the Modified Barium Swallow Impairment Profile, Penetration-Aspiration Scale, the functional oral intake scale, and performance status scale for head and neck cancer, 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.


Criteria:

Inclusion Criteria: - Veteran and non Veterans - have undergone treatment for a primary diagnosis of head and neck cancer (oral cavity, oropharyngeal, and hypopharyngeal) - are 21 years of age - 6 months post head and neck cancer treatment - 6 months post-traditional swallowing treatment with continued dysphagia - 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 Exclusion Criteria: - if they have known allergy or dietary restriction for contrast materials or liquids used during the MBSS or training - 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


NCT ID:

NCT03377270


Primary Contact:

Principal Investigator
Bonnie J. Martin-Harris, PhD
Edward Hines Jr. VA Hospital, Hines, IL

Lina R Kubli, PhD
Phone: (202) 443-5819
Email: Lina.Kubli@va.gov


Backup Contact:

Email: ricardo.gonzalez@va.gov
Ricardo Gonzalez
Phone: (202) 254-0196


Location Contact:

Hines, Illinois 60141
United States

Susan Andrese, MHA
Phone: 708-202-8387
Email: Susan.Andrese@va.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 27, 2021

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