Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer
21 Years
N/A
Both
Oropharyngeal Dysphagia, Oropharyngeal Cancer
Trial Information
Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Modified Barium Swallow Impairment Profile (MBSImP) score
Outcome Description:
Analysis of swallow function during the modified barium swallow study using the MBSImP
Outcome Time Frame:
one week post-intervention and one month post-intervention
Safety Issue:
No
Principal Investigator
Bonnie J Martin-Harris
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ralph H Johnson VA Medical Center, Charleston
Authority:
United States: Federal Government
Study ID:
C7135-R
NCT ID:
NCT01032928
Start Date:
June 2011
Completion Date:
September 2013
Related Keywords:
- Oropharyngeal Dysphagia
- Oropharyngeal Cancer
- Swallowing
- Dysphagia
- Breathing and swallowing
- Oropharyngeal cancer
- Deglutition Disorders
- Oropharyngeal Neoplasms
Name | Location |
|---|---|
| Ralph H Johnson VA Medical Center, Charleston | Charleston, South Carolina 29401-5799 |
