- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University/Ingram Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Skin/soft tissue elasticity assessment
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.
|
Evaluation of secondary lymphedema and fibrosis (LEF) status
Other Names:
Completion of questionnaires
Undergo ultrasound shear wave elastrography
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Elasticity values
Time Frame: Within 2 weeks of initial study visit
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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.
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Within 2 weeks of initial study visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strength of associations of tissue elasticity and current conventional methods
Time Frame: Within 2 weeks of initial study visit
|
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.
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Within 2 weeks of initial study visit
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kenneth Niermann, Vanderbilt University/Ingram Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VICC HN 15135 (Other Identifier: Vanderbilt-Ingram Cancer Center)
- P30CA068485 (U.S. NIH Grant/Contract)
- NCI-2016-00069 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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