The Fibrosis-Lymphedema Continuum in Head and Neck Cancer

Depression Clinical Trial

Official title:

The Fibrosis-Lymphedema Continuum in Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187173
• Other study ID #: 100475
• Status: Completed
• Phase: N/A
• First received: August 20, 2010
• Last updated: April 7, 2017
• Start date: July 2010
• Est. completion date: November 2014

Study information

• Verified date: April 2017
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biomarkers
• Depression
• Fibrosis
• Head and Neck Neoplasms
• Lymphedema
• Polymorphism, Genetic

Locations

Country	Name	City	State
United States	Vanderbilt Ingram Cancer Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevelence and nature of fibrosis and/or lymphedema		baseline, every six wks. first year pot-tx, and 15 & 18 mths post tx.
Primary	Relationships among biological mechanisms of fibrosis and/or lymphedema		baseline, every 6 weeks after tx. for one year, and 15 and 18 months after tx.
Primary	Relationship of fibrosis and/or lymphedema and psychosocial stressors		baseline, every 6 weeks post tx for 1 year and 15 and 18 months post tx.