Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-09-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Dysphagia Oral Pharyngeal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Traditional Therapy Only

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.

Group Type OTHER

Iowa Oral Performance Instrument

Intervention Type DEVICE

the IOPI device is being used to increase tongue strength and endurance

Traditional Therapy with IOPI

Standard of care therapy plus the addition of the IOPI instrument

Group Type EXPERIMENTAL

Iowa Oral Performance Instrument

Intervention Type DEVICE

the IOPI device is being used to increase tongue strength and endurance

Interventions

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Iowa Oral Performance Instrument

the IOPI device is being used to increase tongue strength and endurance

Intervention Type DEVICE

Other Intervention Names

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IOPI

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No