Clinical trial NCT02676752: Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis
Official title: Assessing Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema
Keywords: head and neck cancer
lymphedema and fibrosis
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-02-08
Enrollment: 80
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults 22 years and older that are head and neck cancer survivors and have lymphedema and fibrosis.

Brief summary: This research trial studies skin/soft tissue elasticity in head and neck cancer survivors with lymphedema and fibrosis. Lymphedema and fibrosis is a common effect of head and neck cancer which may lead to skin tightness, pain, and body image issues. Early detection of lymphedema and fibrosis may help reduce serious functional loss of the neck. Shear wave elastography is a technique that provides a quantitative measure of stiffness using a push pulse to generate shear waves within the tissues. Conventional imaging techniques are then used to monitor the shear waves generated through the tissue to calculate the shear wave speed. Shear wave elastography may help obtain an early and accurate measurement of tissue elasticity in head and neck cancer survivors.

Detailed description: PRIMARY OBJECTIVES:

I. To obtain pilot data of the elasticity of skin/soft tissues using shear wave elasticity at the defined anatomical sites in head and neck cancer survivors with lymphedema and fibrosis (LEF).

II. To explore the correlation between elasticity of skin/soft tissues and the following: 1) symptoms as measured by the Lymphedema Symptom Intensity and Distress Survey-Head and Neck (LSIDS-HN); 2) functional impact as measured by Cervical Range of Motion Device and the Vanderbilt Head and Neck Symptom Survey; and 3) physical exam findings as measured by Head and Neck LEF Grading Criteria.

OUTLINE:

Participants will be evaluated for LEF status using the Head and Neck External Lymphedema - Fibrosis (HN-LEF) Grading Criteria and neck range of motion using the Cervical Range of Motion Device. Participants also complete study questionnaires, including Vanderbilt Head and Neck Symptom Survey (VHNSS) and Lymphedema Symptom Intensity and Distress Survey - Head and Neck (LSIDS-H\&N). Participants undergo ultrasound shear wave elastography over 20-25 minutes. Participants' cancer disease and treatment information will be gathered from their medical records.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed cancer involving the head and neck
* Completed all therapy
* No evidence of cancer (NED)
* Ability to understand English in order to complete questionnaires
* Able to provide informed consent

Exclusion Criteria:

* Have medical record documentation of significant cognitive impairment that would preclude the ability to provide informed consent
* Are unwilling to undergo the study assessment
* Have recurrent and/or metastatic cancer

Primary outcomes:
measure: Elasticity values
timeFrame: Within 2 weeks of initial study visit
Secondary outcomes:
measure: Strength of associations of tissue elasticity and current conventional methods
timeFrame: Within 2 weeks of initial study visit
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University/Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University/Ingram Cancer Center
name: Kenneth Niermann
role: PRINCIPAL_INVESTIGATOR
References: