Clinical trial NCT01089803: Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer
Official title: Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Squamous Cell Carcinoma
Laryngeal Cancer
Keywords: laryngectomy
larynx
hypopharynx
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: American Academy of Otolaryngology-Head and Neck Surgery Foundation
name: American Head and Neck Society
First posted: 2010-03-19
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed squamous cell carcinoma of the larynx (cartilage invading-T3 and all T4) or hypopharynx (T2 and T3) for which curative treatment is planned. The tumor must be resectable with total laryngectomy alone as determined by the treating surgeon - this requirement is regardless of whether the surgery of chemoradiation is planned for the patient.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Swallowing Function Scores
timeFrame: 12 months after Treatment
Secondary outcomes:
measure: General Quality of Life
timeFrame: PreTreatment, 6 Months and 12 Months After Treatment
measure: Speech Assessment
timeFrame: PreTreatment, 6 Months and 12 Months After Treatment
measure: Head and Neck Quality of Life
timeFrame: PreTreatment, 6 Months and 12 Month After Treatment
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Bevan Yueh, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: