Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer
Status: | Completed |
---|---|
Conditions: | Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | September 2009 |
End Date: | August 2015 |
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.
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.
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.
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.
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.
We found this trial at
1
site
425 E River Pkwy # 754
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
612-624-2620
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Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
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