Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer (RSPT)
Cancers of the head and neck require surgical, radiation, and chemotherapy treatments that are intended to cure the disease. These treatments have toxic effects on muscles and structures that are necessary to swallow safely and efficiently. The resulting swallowing problems (dysphagia) often remain chronic for Veterans and interfere with their ability to eat and drink. The cost burden to the VA health system is high. There is an urgent need to develop rehabilitative treatments that lessen these burdens. The proposed research is designed to test a novel swallowing therapy that includes the coordination of breathing with swallowing. Our study will train medically and surgically treated, chronically dysphagic Veterans with histories of oropharyngeal cancer in a novel therapy that involves both swallowing and respiratory systems. If the therapy is found to be effective, the long term goal of the project is to extend the study to a multi-site, clinical trial and test the longstanding effect of this treatment compared to other swallowing therapies on swallowing function, QOL and cost.
Behavioral: Respiratory-Swallow Phase training
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer|
- Optimal Respiratory - Swallow Phase [ Time Frame: Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks ] [ Designated as safety issue: No ]Respiratory swallow patterns were collected using nasal airflow and respiratory inductance plethysmography (RIP) of each swallow during the modified barium swallow study. The movements of the ribcage and abdomen were recorded using RIP; data synchronized and recorded using the KayPentax Digital Swallow Workstation Signals Lab. Subjects were categorized as optimal (expiratory-expiratory) versus non-optimal (non-expiratory-expiratory).
- Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP) [ Time Frame: Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks ] [ Designated as safety issue: No ]Analysis of the percentage of impaired swallow components using a dichotomized MBSImP scoring system
- Percentage of Impairment According to the Penetration-Aspiration Scale [ Time Frame: Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks ] [ Designated as safety issue: No ]The penetration aspiration scale is a validated 8 point interval scale used to describe penetration and aspiration events. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled. Scores < 3 are considered to be normal. For the purpose of our study scores were dichotimized to normal and impaired.
|Study Start Date:||June 2011|
|Study Completion Date:||September 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Respiratory Phase Training
Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns participated in up to 8 sessions of respiratory phase training to learn an optimal respiratory - swallow phase pattern
Behavioral: Respiratory-Swallow Phase training
Patients were presented with visually guided respiratory feedback to train optimal respiratory-swallow coordination patterns.
Swallowing impairments (dysphagia) represent the highest functional morbidity in veteran patients treated for oropharyngeal cancers with either surgical approaches followed by radiation or with more recent organ-preservation protocols. The nature of the impairments is often resistive to treatment and results in life-long health consequences and high cost burden on the VA health system. Recent preliminary data have linked alterations in the otherwise highly stable respiratory-swallowing phase pattern relationships to the swallowing impairment and penetration/aspiration and in this patient group. The immediate goal of this clinical trial is to test the effect of a novel respiratory-swallow intervention on swallowing impairment and penetration/aspiration in a cohort of chronically dysphagic veterans following treatment for oropharyngeal cancer. Patients presenting with a "non-optimal" respiratory-swallow phase pattern during liquid swallows and measurable swallowing impairment will learn an "optimal" physiologic pattern that facilitates both airway protective and mechanical advantages during swallowing. The broad goal of this research is to develop ideal respiratory-swallowing phase training methods and regimens that alone or combined with traditional swallowing treatments improve swallowing function in the acute phases of recovery and improve long term patient outcome. Our intention is to use these preliminary data to motivate a larger clinical trial to compare the effect of respiratory-swallow phase training with other evidenced based methods of swallowing treatment and expand the approach to other patient groups that have indications of respiratory-swallow phase impairments (e.g. pulmonary disease and stroke) contributing to impaired swallowing function
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032928
|United States, South Carolina|
|Ralph H Johnson VA Medical Center, Charleston|
|Charleston, South Carolina, United States, 29401-5799|
|Principal Investigator:||Bonnie J Martin-Harris||Ralph H Johnson VA Medical Center, Charleston|