Nashville, Tennessee 37232


Purpose:

This four-year, prospective, longitudinal study will evaluate and validate a patient-reported outcome measure, clinician-reported outcome measures, and imaging techniques in assessing characteristics, trajectory, and progression of lymphedema and fibrosis (LEF) in oral cavity and oropharyngeal cancer patients. This clinical trial studies patient-and-clinician-reported measures as well as standard imaging methods to see how accurate they are in identifying and evaluating lymphedema (swelling) or fibrosis (tough or tight tissue) in the head and neck region of patients receiving treatment for newly diagnosed stage II-IV oral cavity or oropharyngeal cancer. Lymphedema and fibrosis (LEF) can lead to physical symptoms, such as trouble swallowing and chewing, as well as psychological and emotional symptoms, such as negative body image and avoiding social interactions. Finding an accurate test to identify and evaluate LEF may allow doctors to treat LEF more quickly and control symptoms more effectively, and thus provide patients with a better quality of life.


Study summary:

The goal of this proposed study is to establish a valid, clinically useful measurement battery for head and neck LEF by achieving these specific aims: Aim 1: To determine the reliability and validity of the patient-reported outcome measure (LSIDS-H&N) for assessing LEF-related symptoms in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival. Aim 2: To determine the reliability and validity of the clinician-reported outcome measures (HN-LEF Grading Criteria and Modified Patterson Scale) for assessing external and internal LEF in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival. Aim 3: To determine the reliability and validity of imaging techniques (CT scan and ultrasonography) in identifying site-specific LEF in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival.


Criteria:

Inclusion Criteria: - a newly diagnosed, histologically proven cancer arising from the oral cavity and oropharynx - tumor stage II or greater - age ≥ 21 years old - willing and able to undergo study assessment - able to speak and read English and understand Informed Consent. Exclusion Criteria: - have medical record documentation of cognitive impairment that would preclude the ability to provide informed consent - are unwilling to undergo routine follow-up - have recurrent cancer - have any other active cancer.


NCT ID:

NCT02412241


Primary Contact:

Principal Investigator
Jie Deng
Vanderbilt-Ingram Cancer Center

VICC Clinical Trials Information Program
Phone: 800-811-8480


Backup Contact:

N/A


Location Contact:

Nashville, Tennessee 37232
United States

VICC Clinical Trials Information Program
Phone: 800-811-8480

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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