The Fibrosis-Lymphedema Continuum in Head and Neck Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sheila H. Ridner, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01187173
First received: August 20, 2010
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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.


Condition
Head and Neck Neoplasms
Fibrosis
Lymphedema
Cytokines
Polymorphism, Genetic
Depression

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Fibrosis-Lymphedema Continuum in Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Prevelence and nature of fibrosis and/or lymphedema [ Time Frame: baseline, every six wks. first year pot-tx, and 15 & 18 mths post tx. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2011
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187173

Locations
United States, Tennessee
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
  More Information

No publications provided

Responsible Party: Sheila H. Ridner, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01187173     History of Changes
Other Study ID Numbers: 100475
Study First Received: August 20, 2010
Last Updated: December 18, 2012
Health Authority: United States: Vanderbilt Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Depression
Depressive Disorder
Fibrosis
Head and Neck Neoplasms
Lymphedema
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes
Neoplasms by Site
Lymphatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014