The Fibrosis-Lymphedema Continuum in Head and Neck Cancer

NCT01187173 | Completed

• 1 other identifier: 100475
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Prevelence and nature of fibrosis and/or lymphedema

  baseline, every six wks. first year pot-tx, and 15 & 18 mths post tx.

• 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.

• 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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood from blood draws

MeSH Terms

Conditions

Head and Neck Neoplasms; Fibrosis; Lymphedema; Depression

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 20, 2010
• First Posted: August 23, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

US (1)