NCT02676752

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

Assessing Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphedema

Interventions

Type	Name	Description
PROCEDURE	Medical Examination	Evaluation of secondary lymphedema and fibrosis (LEF) status
OTHER	Questionnaire Administration	Completion of questionnaires
PROCEDURE	Shear Wave Elastography	Undergo ultrasound shear wave elastrography

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-04-01
• Completion: 2021-08-01
• First posted: 2016-02-08
• Last updated: 2022-02-09

Locations

1 site across 1 country: United States