Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer (RSPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01032928
First received: December 14, 2009
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Oropharyngeal Dysphagia
Oropharyngeal Cancer
Behavioral: Respiratory-Swallow Phase training
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Modified Barium Swallow Impairment Profile (MBSImP) score [ Time Frame: one week post-intervention and one month post-intervention ] [ Designated as safety issue: No ]
    Analysis of swallow function during the modified barium swallow study using the MBSImP


Secondary Outcome Measures:
  • Penetration-Aspiration Scale [ Time Frame: one week post-intervention and one month post-intervention ] [ Designated as safety issue: No ]
  • Oral Intake Status Scale [ Time Frame: one week post-intervention and one month post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 58
Study Start Date: June 2011
Study Completion Date: September 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns
Behavioral: Respiratory-Swallow Phase training
Will present patients with visually guided, respiratory feedback and train optimal respiratory-swallow coordination patterns, thereby providing the airway protection and mechanical benefits that have been observed in healthy individuals.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032928

Locations
United States, South Carolina
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, United States, 29401-5799
Sponsors and Collaborators
Investigators
Principal Investigator: Bonnie J Martin-Harris Ralph H Johnson VA Medical Center, Charleston
  More Information

Additional Information:
No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01032928     History of Changes
Other Study ID Numbers: C7135-R, RX000152-01A1
Study First Received: December 14, 2009
Last Updated: December 4, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Swallowing
Dysphagia
Breathing and swallowing
Oropharyngeal cancer

Additional relevant MeSH terms:
Oropharyngeal Neoplasms
Deglutition Disorders
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014