Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer

NCT01089803 | Completed

• 2 other identifiers: 2008NTLS1040809M45481
• Study Type: observational
• Target: 279
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Carcinoma; Laryngeal Cancer

Keywords

laryngectomy; larynx; hypopharynx

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• General Quality of Life

  PreTreatment, 6 Months and 12 Months After Treatment

• Speech Assessment

  PreTreatment, 6 Months and 12 Months After Treatment

• Head and Neck Quality of Life

  PreTreatment, 6 Months and 12 Month After Treatment

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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• Voluntary written informed consent with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• American Academy of Otolaryngology-Head and Neck Surgery Foundation: collaborator
• American Head and Neck Society: collaborator

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Laryngeal Neoplasms; Laryngeal Diseases

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Officials

• Bevan Yueh, MD, MPH

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 19, 2010
• Study Start: September 1, 2009
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 4, 2015

Record last verified: 2015-12

Locations

US (1)