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OpenTrials
Completed

NCT Number: NCT00584129

Pre-treatment Exercises Versus Post-treatment Exercises for Dysphagia

The purpose of this project is to determine if pre-treatment swallowing exercises can improve post-treatment swallowing function in patients undergoing radiation with or without chemotherapy for advanced squamous cell carcinoma of the head and neck.

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Key information

Conditions

Head and Neck Cancer Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB Division of Otolaryngology

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stage III or IV squamous cell cancer of teh pharynx and larynx
  • Patients who will be receiving chemoradiation
  • Age 19 years of age or older
  • Must sign informed consent.

Exclusion criteria

  • Prior cancer diagnosis
  • Metastatic disease
  • Cognitive Impairment

Treatment and study plan

Pre-treatment swallowing exercises

Other

Swallowing exercises will be started pre-treatment with radiation.

Post-treatment swallowing exercises.

Other

Patients to start swallowing exercises after completion of radiation therapy.

Primary outcomes

  1. To test whether pre-treatment swallowing exercises compared with "usual care" (where exercises are taught post-treatment) improves quality of life in patients undergoing chemoradiation therapy for advanced head and neck cancer.

    Time frame: 8 weeks, 6 months, 12 months post radiation treatment

Secondary outcomes

  1. To test whether pre-treatment swallowing exercises compared with usual care improves secondary outcome measures related to dysphagia in this patient population.

    Time frame: 8 weeks, 6 mnths and 12 months post radiation.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • American Academy of Otolaryngology-Head and Neck Surgery Foundation

Registry information

Official study title

Determining the Efficacy of Pre-treatment Swallowing Therapy as a Means to Improve Dysphagia Quality of Life When Compared to Post-Treatment Therapy.

Important dates

Study start
2006
Primary completion
2013
Study completion
2014
First posted
Jan 2, 2008
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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