Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis

Vanderbilt University Medical Center

Status: Completed

Conditions: Lymphedema

Treatments: Procedure: Medical Examination; Other: Questionnaire Administration; Procedure: Shear Wave Elastography

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02676752

VICC HN 15135 (Other Identifier)

NCI-2016-00069 (Registry Identifier)

P30CA068485 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Skin/soft tissue elasticity assessment

Description:

Participants will be evaluated for LEF status using the HN-LEF Grading Criteria and neck range of motion using the Cervical Range of Motion Device. Participants also complete study questionnaires, including VHNSS and 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.

Treatment:

Procedure: Shear Wave Elastography

Other: Questionnaire Administration

Procedure: Medical Examination