The Fibrosis-Lymphedema Continuum in Head and Neck Cancer

Completed

Conditions studied: Head and Neck Neoplasms, Fibrosis, Lymphedema, Biomarkers, Polymorphism, Genetic, Depression

In brief

Goal: The primary goal of this study is to longitudinally investigate, in head and neck cancer (HNC) patients, the potential fibrosis-lymphedema continuum. Specifically, we will examine the development, patterns, progression, and prevalence of late-effect fibrosis and/or lymphedema, explore potential biological correlatives including pro-inflammatory cytokines and genetic polymorphisms, and evaluate the relationship among late-effect fibrosis and/or lymphedema and select psychosocial stressors that potentially interact with cytokine pathways. H: A minimum of 20 percent of HNC patients will experience late-effect fibrosis and/or lymphedema. H: We will be able to differentiate characteristics patterns of the development of late-effect fibrosis and/or lymphedema. H: We will be able to differentiate patterns of symptoms associated with late-effect fibrosis and/or lymphedema. H: We will be able to differentiate patterns of inflammatory response and the development of late-effect fibrosis and/or lymphedema. H: Select polymorphisms will increase the likelihood of development of late-effect fibrosis and/or lymphedema. H: Incidence and severity of late-effect fibrosis and/or lymphedema will correlate with total dose of radiation to involved anatomical site. H: HNC patients with fibrosis and/or lymphedema experience greater levels of depression and social withdrawal than those without these conditions.

Key facts

Study ID

NCT01187173

Run by

Vanderbilt University

People needed

100

Starts

2010-07-01

Expected to finish

2014-11-01

Last updated by the study team

2017-04-10

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• newly diagnosed, histologically proven carcinoma involving the head and neck
• Stage II or greater
• age of 21 or over
• willing and able to undergo baseline and follow-up assessment at the VICC Nashville, or the Nashville Veterans Administration Medical Center (Nashville VA
• the ability to speak English

You may not qualify if…

• medical record documentation of cognitive impairment that would preclude the ability to provide informed consent
• unwilling to undergo routine follow-up at VICC Nashville or the Nashville VA
• recurrent cancer

Where it is running

• Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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