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Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer

NCT ID: NCT01089803

Last Updated: 2015-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

279 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2015-08-31

Brief Summary

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The purpose of this prospective, multi-institutional, observational cohort study is to determine if an initial surgical approach leads to better function and quality of life than primary chemoradiation in a subset of patients with advanced hypopharyngeal and laryngeal cancers.

Detailed Description

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At the time of registration patients will be categorized into 2 groups based on the initial treatment plan as either chemoradiation-based or surgically-based (laryngectomy). Treatment will be assigned by the patient's physician, it will not be assigned by the study.

Patients will be asked to complete a series of 4 questionnaires addressing swallowing function, generic health status, head and neck cancer-specific quality of life, and self-reported speech function at 3 time points (baseline, 6 months and 12 months after the end of treatment). The treating physician will provide basic clinical information at these same time points. In centers where swallowing and voice assessments are done as part of standard of care, data from these studies will also be provided.

Study entry is open to all adults regardless of gender or ethnic background. Specific information regarding the definitive treatment (surgery or chemoradiation) will be provided to the patient by the treating physician as part of the routine standard of care. Any treatment related side effects, as well as the duration of therapy and follow-up will be managed by the treating physician. Participation in this study will have no effect on the initial treatment decisions or the course of care.

Conditions

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Squamous Cell Carcinoma Laryngeal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients Treated with Laryngectomy

Patients initially treated with laryngectomy and followed for 12 months after receiving this treatment.

No interventions assigned to this group

Patients Treated with Chemoradiation

Patients treated initially with chemoradiation and followed for 12 months after receiving treatment.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Willingness and ability to complete self-administered follow-up questionnaires over the course of one year as determined by a member of the research team
* Voluntary written informed consent with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
* Must be at least 18 years of age

Exclusion Criteria

* Require a resection that would involve more than the standard laryngectomy (total pharyngectomy, esophagectomy)
* Undergo partial laryngectomy, when open or endoscopic
* Have previously altered anatomy of the upper aerodigestive tract
* Have pre-existing dysphagia unrelated to the tumor, or neurologic disorders that could affect swallowing (Parkinson's, cerebrovascular accidents)
* Have prior malignant disease of the upper aerodigestive tract
* Have prior radiation therapy to the head and neck region
* Metastatic disease
* Unable to complete self-administered questionnaires written in simple English for cognitive, psychiatric, or other reasons that in the opinion of the enrolling investigator is likely to interfere with participation in this clinical study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Academy of Otolaryngology-Head and Neck Surgery Foundation

OTHER

Sponsor Role collaborator

American Head and Neck Society

OTHER

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bevan Yueh, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

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Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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0809M45481

Identifier Type: OTHER

Identifier Source: secondary_id

2008NTLS104

Identifier Type: -

Identifier Source: org_study_id