Trial Information

The Fibrosis-Lymphedema Continuum in Head and Neck Cancer

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.