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Completed

NCT Number: NCT01032928

Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • at least 21 years of age
  • agreed to participate in this study and signed an informed consent, either completed by the participant or designated other
  • have chronic impairments in oropharyngeal swallowing function following chemotherapy, radiation, and/or surgical intervention for the treatment of first time diagnosis of squamous cell carcinoma of the head and neck
  • have completed medical treatments for his/her cancer and any traditional swallowing therapy at least 6 months earlier
  • pass a cognitive screening (COGNISTAT)
  • have at least one area of impairment (initiation of pharyngeal swallow, anterior hyolaryngeal excursion, extent and duration of PES opening, tongue base retraction, pharyngeal residue) as indicated by the results of the pre-intervention MBSImP (total sum MBSImP
  • have PAS scores >/= 3 on 10% of swallows on pre-intervention MBSS
  • have a non-optimal (E-I, I-E, or I-I) breathing pattern on 60% of trial swallows.

Exclusion criteria

  • known allergy or dietary restriction for food or contrast materials used during the exam
  • evidence of persistent or recurrent disease on physical examination of the head and neck
  • evidence of esophageal stricture noted on MBS
  • recurrent oropharyngeal cancer and/or are being treated for other cancer(s) concurrently
  • severe COPD (see Pulmonary Criteria below)
  • nasogastric feeding tube
  • recent change in swallowing status characterized by increase in perceived or observed -swallowing problems by patient, family or testing SLP
  • any co-occurring neurological impairment affecting muscle strength and/or cognition
  • history of aspiration pneumonia over the past 12 months.
  • fail cognitive screening
  • absence of swallowing impairment
  • evidence of esophageal stricture on MBS
  • inability to tolerate at least one of the liquid barium consistencies
  • consistent optimal respiratory-swallow phase patterning

Treatment and study plan

Respiratory-Swallow Phase training

Behavioral

Patients were presented with visually guided respiratory feedback to train optimal respiratory-swallow coordination patterns.

Primary outcomes

  1. 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

    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).

Secondary outcomes

  1. 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

    Analysis of the percentage of impaired swallow components using a dichotomized MBSImP scoring system

  2. 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

    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.

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Acronym: RSPT

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 16, 2009
Registry last updated
Jan 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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