Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer

Squamous Cell Carcinoma Clinical Trial

Official title:

Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089803
• Other study ID #: 2008NTLS104
• Secondary ID: 0809M45481
• Status: Completed
• Phase: N/A
• First received: March 17, 2010
• Last updated: December 3, 2015
• Start date: September 2009
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Laryngeal Cancer
• Laryngeal Neoplasms
• Squamous Cell Carcinoma

Locations

Country	Name	City	State
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	American Academy of Otolaryngology-Head and Neck Surgery Foundation, American Head and Neck Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Swallowing Function Scores	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.	12 months after Treatment	No
Secondary	General Quality of Life	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).	PreTreatment, 6 Months and 12 Months After Treatment	No
Secondary	Speech Assessment	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.	PreTreatment, 6 Months and 12 Months After Treatment	No
Secondary	Head and Neck Quality of Life	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.	PreTreatment, 6 Months and 12 Month After Treatment	No