Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy

Brief Title

Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy

Official Title

Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy

Brief Summary

      Patients with head and neck cancer treated with chemoradiation, often develop a treatment
      associated dysphagia. The common complaint is foods sticking in the pharynx. This study seeks
      to test the Iowa Oral Performance Instrument (IOPI) in the management of treatment induced
      dysphagia following chemoradiation for oral, pharyngeal, laryngeal, hypopharyngeal cancer.
      This pilot study seeks to compare standard exercise therapy plus IOPI to standard exercise
      alone to determine if recovery is enhanced and to determine if rate of recovery is
      accelerated.
    



Study Type

Interventional


Primary Outcome

Tongue Pressure Generation (i.e. Tongue Strength) in Kilopascals (kPa) Using the IOPI Device

Secondary Outcome

 Airway Protection During Swallowing

Condition

Dysphagia

Intervention

Iowa Oral Performance Instrument

Study Arms / Comparison Groups

 Traditional Therapy Only
Description:  Standard of care therapy for qualifying population (with opportunity to "crossover" and be assigned to the IOPI device if so desired after initial 8 week standard of care therapy completion.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

26

Start Date

January 2016

Completion Date

September 6, 2019

Primary Completion Date

January 31, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  diagnosed with oral, oropharyngeal, hypopharyngeal or laryngeal cancer having
             non-surgical treatment with chemoradiation, or radiation therapy alone, resulting in
             treatment associated dysphagia.

        Exclusion Criteria:

          -  unable to adhere to assigned therapy program due to cognitive deficits

          -  surgical treatment for head and neck cancer

          -  unable to give informed consent
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02564887

Organization ID

PRO15080566


Responsible Party

Sponsor-Investigator

Study Sponsor

Jonas Johnson


Study Sponsor

, , 


Verification Date

March 2020