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

Primary Purpose

Oropharyngeal Dysphagia, Oropharyngeal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Respiratory-Swallow Phase training
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oropharyngeal Dysphagia focused on measuring Swallowing, Dysphagia, Breathing and swallowing, Oropharyngeal cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ralph H Johnson VA Medical Center, Charleston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Respiratory Phase Training

Arm Description

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

Outcomes

Primary Outcome Measures

Optimal Respiratory - Swallow Phase
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 Outcome Measures

Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
Analysis of the percentage of impaired swallow components using a dichotomized MBSImP scoring system
Percentage of Impairment According to the Penetration-Aspiration Scale
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.

Full Information

First Posted
December 14, 2009
Last Updated
December 9, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT01032928
Brief Title
Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer
Acronym
RSPT
Official Title
Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Dysphagia, Oropharyngeal Cancer
Keywords
Swallowing, Dysphagia, Breathing and swallowing, Oropharyngeal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Respiratory Phase Training
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Respiratory-Swallow Phase training
Intervention Description
Patients were presented with visually guided respiratory feedback to train optimal respiratory-swallow coordination patterns.
Primary Outcome Measure Information:
Title
Optimal Respiratory - Swallow Phase
Description
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).
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
Secondary Outcome Measure Information:
Title
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
Description
Analysis of the percentage of impaired swallow components using a dichotomized MBSImP scoring system
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
Title
Percentage of Impairment According to the Penetration-Aspiration Scale
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonnie J Martin-Harris
Organizational Affiliation
Ralph H Johnson VA Medical Center, Charleston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ralph H Johnson VA Medical Center, Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5799
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25498307
Citation
Martin-Harris B, McFarland D, Hill EG, Strange CB, Focht KL, Wan Z, Blair J, McGrattan K. Respiratory-swallow training in patients with head and neck cancer. Arch Phys Med Rehabil. 2015 May;96(5):885-93. doi: 10.1016/j.apmr.2014.11.022. Epub 2014 Dec 11.
Results Reference
derived
Links:
URL
http://www.muschealth.com/ent
Description
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