Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy

Jonas Johnson

Status: Terminated

Conditions: Dysphagia; Oral Pharyngeal Cancer

Treatments: Device: Iowa Oral Performance Instrument

Study type: Interventional

Funder types: Other

Identifiers

NCT02564887

PRO15080566

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Traditional Therapy Only

Other group

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.

Treatment:

Device: Iowa Oral Performance Instrument

Traditional Therapy with IOPI

Experimental group

Description:

Standard of care therapy plus the addition of the IOPI instrument

Treatment:

Device: Iowa Oral Performance Instrument