Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer
RSPT
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2009
CompletedFirst Posted
Study publicly available on registry
December 16, 2009
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
December 4, 2014
CompletedJanuary 1, 2015
December 1, 2014
2.1 years
December 14, 2009
November 25, 2014
December 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
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 Outcomes (2)
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks
Percentage of Impairment According to the Penetration-Aspiration Scale
Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks
Study Arms (1)
Respiratory Phase Training
EXPERIMENTALChronically 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
Interventions
Patients were presented with visually guided respiratory feedback to train optimal respiratory-swallow coordination patterns.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, 29401-5799, United States
Related Publications (1)
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.
PMID: 25498307DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Bonnie Martin Harris
- Organization
- Ralph H Johnson VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Bonnie J Martin-Harris
Ralph H Johnson VA Medical Center, Charleston
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2009
First Posted
December 16, 2009
Study Start
June 1, 2011
Primary Completion
July 1, 2013
Study Completion
September 1, 2013
Last Updated
January 1, 2015
Results First Posted
December 4, 2014
Record last verified: 2014-12