We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01089803
Recruitment Status : Completed
First Posted : March 19, 2010
Last Update Posted : December 4, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Squamous Cell Carcinoma Laryngeal Cancer

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.

Study Design

Study Type : Observational
Actual Enrollment : 279 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer
Study Start Date : September 2009
Primary Completion Date : August 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Patients Treated with Laryngectomy
Patients initially treated with laryngectomy and followed for 12 months after receiving this treatment.
Patients Treated with Chemoradiation
Patients treated initially with chemoradiation and followed for 12 months after receiving treatment.

Outcome Measures

Primary Outcome Measures :
  1. Swallowing Function Scores [ Time Frame: 12 months after Treatment ]
    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.

Secondary Outcome Measures :
  1. General Quality of Life [ Time Frame: PreTreatment, 6 Months and 12 Months After Treatment ]
    The SF-12 Quality of Life questionnaire will be used to assess general health status. The SF-12 contains one or two items that measure each of eight domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS).

  2. Speech Assessment [ Time Frame: PreTreatment, 6 Months and 12 Months After Treatment ]
    Speech analysis will focus primarily on speech intelligibilty and acceptability to both clinicians and naive listeners, and less on voice quality per se using the Voice Handicap Index. The Voice Handicap Index (VHI) measures the influence of voice problems on a patient's quality of life.

  3. Head and Neck Quality of Life [ Time Frame: PreTreatment, 6 Months and 12 Month After Treatment ]
    The University of Washington Quality of Life Assessment Questionnaire will be administered. This questionnaire is specifically designed to capture head and neck cancer-specific function.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01089803

United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
American Academy of Otolaryngology-Head and Neck Surgery Foundation
American Head and Neck Society
Principal Investigator: Bevan Yueh, MD, MPH Masonic Cancer Center, University of Minnesota
More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01089803     History of Changes
Other Study ID Numbers: 2008NTLS104
0809M45481 ( Other Identifier: IRB, University of Minnesota )
First Posted: March 19, 2010    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Laryngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases