Lymphedema Clinical Trial
Official title:
Assessing Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors
Verified date | February 2022 |
Source | Vanderbilt-Ingram Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt-Ingram Cancer Center | National Cancer Institute (NCI) |
United States,
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 |
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