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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00069 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| VICC HN 15135 | Other Identifier | Vanderbilt-Ingram Cancer Center | |
| P30CA068485 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Examination | Procedure | Evaluation of secondary lymphedema and fibrosis (LEF) status |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adults 22 years and older that are head and neck cancer survivors and have lymphedema and fibrosis.
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Niermann | Vanderbilt University/Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
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| Label | URL |
|---|---|
| Vanderbilt-Ingram Cancer Center, Find a Clinical Trial | View source |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D006258 | Head and Neck Neoplasms |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000070536 | Independent Medical Evaluation |
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D032763 | Behavior Control |
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| Questionnaire Administration | Other | Completion of questionnaires |
|
| Shear Wave Elastography | Procedure | Undergo ultrasound shear wave elastrography |
|
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| Within 2 weeks of initial study visit |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |