Clinical trial NCT01187173: The Fibrosis-Lymphedema Continuum in Head and Neck Cancer
Official title: The Fibrosis-Lymphedema Continuum in Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Neoplasms
Fibrosis
Lymphedema
Biomarkers
Polymorphism, Genetic
Depression
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2010-08-23
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prevelence and nature of fibrosis and/or lymphedema
timeFrame: baseline, every six wks. first year pot-tx, and 15 & 18 mths post tx.
measure: Relationships among biological mechanisms of fibrosis and/or lymphedema
timeFrame: baseline, every 6 weeks after tx. for one year, and 15 and 18 months after tx.
measure: Relationship of fibrosis and/or lymphedema and psychosocial stressors
timeFrame: baseline, every 6 weeks post tx for 1 year and 15 and 18 months post tx.
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Ingram Cancer Center
state: Tennessee
Study officials:
References: