An observational study in Head and Neck Neoplasms, Fibrosis and Lymphedema, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-04-10.
Sponsored by Vanderbilt University · Observational
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.
Background: The use of aggressive treatment for HNC, particularly combined modality treatment regimens has resulted in an increase in survival. Unfortunately, this improvement has come with a marked increase in acute and late-effects. These undesirable treatment outcomes exact a heavy toll on functional capacity, contribute to a myriad of problematic physical and psychological symptoms, negatively impact Quality of Life, and likely create a significant economic burden to both the patients and the health care system.
Objective: This four year, longitudinal study will examine the development, patterns, nature, progression, and prevalence of late-effect fibrosis and/or lymphedema, explore potential host biological correlatives (pro-inflammatory cytokines and genetic polymorphisms), and examine select psychological stressors (depression, social withdrawal), associated with late-effect fibrosis and lymphedema in HNC survivors.
Specific Aims:1. To determine the prevalence and nature of late-effect (≥3 months post-treatment) fibrosis and/or lymphedema in HNC patients. 2. To explore the relationships among the biological mechanisms of inflammatory response, genetic polymorphisms, treatment factors, and late-effect fibrosis and/or lymphedema in HNC patients. 3. To explore the relationships among late-effect fibrosis and/or lymphedema and psychosocial stressors (depression and social withdrawal) in HNC patients.
Study Design: HNC patients will be assessed at baseline, end of treatment (EOT), and every six weeks after treatment up to one year after treatment, and twice more at 15 and 18 months post-treatment. These intervals were chosen to reduce subject burden as they routinely coincide with scheduled laryngoscopic procedures. At baseline, the follow assessment will be undertaken: 1) demographic information and alcohol and tobacco use history; 2) disease characteristics; 3) presence of tumor related fibrosis and/or lymphedema (laryngoscope with digital photographs and scoring of internal lymphedema with Patterson Scale) and external fibrosis/lymphedema with digital photography, physical exam for fibrosis/lymphedema using the Foldi criteria, and CT scans; 4) blood for inflammatory mediators and polymorphisms; 5) psychosocial assessments (Center for epidemiological Studies Depression Scale, Liebowitz Anxiety Scale); and 6) functional assessments (MBVS, Cervical Range of Motion [CROM], Neck Disability Index and VHNSS). Post-treatment, and every scheduled assessment thereafter, patients will undergo repeat assessments for everything except: demographic information, medical history, ETOH and smoking history, polymorphisms and MBVs.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
The targeted population consists of patients with carcinoma of the head and neck. Subjects will be recruited from newly diagnosed patients with carcinoma of the head and neck undergoing treatment at the VICC, Vanderbilt Cool Springs Clinic, and the Nashville Veterans Administration (VA) Medical Center.
Exclusion Criteria:
Prevelence and nature of fibrosis and/or lymphedema
Time frame: baseline, every six wks. first year pot-tx, and 15 & 18 mths post tx.
Relationships among biological mechanisms of fibrosis and/or lymphedema
Time frame: baseline, every 6 weeks after tx. for one year, and 15 and 18 months after tx.
Relationship of fibrosis and/or lymphedema and psychosocial stressors
Time frame: baseline, every 6 weeks post tx for 1 year and 15 and 18 months post tx.
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Vanderbilt University