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

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676752
• Other study ID #: VICC HN 15135
• Secondary ID: NCI-2016-00069VI
• Status: Completed
• Start date: September 2016
• Est. completion date: August 2021

Study information

• Verified date: February 2022
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2021
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Lymphedema

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elasticity values	Descriptive statistics will be used to describe data from elasticity measure. Of particular interest will be the measures of central tendency and variability at the multiple sites. Sites with higher variability (coefficient of variation) that others may be indicative of less reliable assessment.	Within 2 weeks of initial study visit
Secondary	Strength of associations of tissue elasticity and current conventional methods	Correlation coefficients will be used to assess the strength of the associations of the elasticity values with the respective LEF grades (HN-LEF) for the respective sites. Those values will also be correlated with Vanderbilt Head and Neck Symptom Survey and HN-LSIDS symptom and Cervical Range of Motion scores. Due to the large number of correlations proposed in this study, effect sizes (strength of the associations) and clinically significant patterns will be of much greater importance than statistical significance.	Within 2 weeks of initial study visit

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial