Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborators:
American Academy of Otolaryngology-Head and Neck Surgery Foundation
American Head and Neck Society
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01089803
First received: March 17, 2010
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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
Squamous Cell Carcinoma
Laryngeal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Swallowing Function Scores [ Time Frame: 12 months after Treatment ] [ Designated as safety issue: No ]
    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:
  • General Quality of Life [ Time Frame: PreTreatment, 6 Months and 12 Months After Treatment ] [ Designated as safety issue: No ]
    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).

  • Speech Assessment [ Time Frame: PreTreatment, 6 Months and 12 Months After Treatment ] [ Designated as safety issue: No ]
    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.

  • Head and Neck Quality of Life [ Time Frame: PreTreatment, 6 Months and 12 Month After Treatment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 320
Study Start Date: September 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089803

Contacts
Contact: Bevan Yueh, MD, MPH 612-625-2410 byueh@umn.edu
Contact: Patricia Fernandes, DDS, MS 612-626-3018 ferna079@umn.edu

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Bevan Yueh, MD, MPH    612-625-2410    byueh@umn.edu   
Principal Investigator: Bevan Yueh, MD, MPH         
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
Investigators
Principal Investigator: Bevan Yueh, MD, MPH Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01089803     History of Changes
Other Study ID Numbers: 2008NTLS104, 0809M45481
Study First Received: March 17, 2010
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014