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Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer

18 Years
Open (Enrolling)
Squamous Cell Carcinoma, Laryngeal Cancer

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Trial Information

Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer

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.

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withdrawn by the patient at any time without prejudice to future medical care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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Swallowing Function Scores

Outcome Description:

The primary outcome will be self-reported swallowing function (M.D. Anderson Dysphagia Inventory questionnaire - MDADI) 12 months after treatment. Analysis will compare MDADI scores of patients treated initially with laryngectomy vs. those of patients treated initially with chemoradiation.

Outcome Time Frame:

12 months after Treatment

Safety Issue:


Principal Investigator

Bevan Yueh, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Institutional Review Board

Study ID:




Start Date:

September 2009

Completion Date:

February 2014

Related Keywords:

  • Squamous Cell Carcinoma
  • Laryngeal Cancer
  • laryngectomy
  • larynx
  • hypopharynx
  • Carcinoma
  • Laryngeal Neoplasms
  • Carcinoma, Squamous Cell



Masonic Cancer Center, University of MinnesotaMinneapolis, Minnesota  55455