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

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ClinicalTrials.gov Identifier: NCT02676752
Recruitment Status : Recruiting
First Posted : February 8, 2016
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kenneth Niermann, Vanderbilt-Ingram Cancer Center

Brief 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.

Condition or disease Intervention/treatment
Lymphedema Procedure: Medical Examination Other: Questionnaire Administration Procedure: Shear Wave Elastography

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.


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Assessing Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.
Procedure: Medical Examination
Evaluation of secondary lymphedema and fibrosis (LEF) status
Other Names:
  • Exam
  • Examination
  • Medical Assessment
  • Medical Exam
  • Medical Inspection

Other: Questionnaire Administration
Completion of questionnaires

Procedure: Shear Wave Elastography
Undergo ultrasound shear wave elastrography
Other Name: Transient Elastography




Primary Outcome Measures :
  1. Elasticity values [ Time Frame: Within 2 weeks of initial study visit ]
    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.


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults 22 years and older that are head and neck cancer survivors and have lymphedema and fibrosis.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02676752


Contacts
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Contact: Vanderbilt-Ingram Service for Timely Access 800-811-8480

Locations
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United States, Tennessee
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Kenneth J. Niermann    615-322-2555    ken.niermann@vanderbilt.edu   
Principal Investigator: Kenneth J. Niermann         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kenneth Niermann Vanderbilt University/Ingram Cancer Center

Additional Information:
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Responsible Party: Kenneth Niermann, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT02676752     History of Changes
Other Study ID Numbers: VICC HN 15135
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 )
First Posted: February 8, 2016    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

Keywords provided by Kenneth Niermann, Vanderbilt-Ingram Cancer Center:
head and neck cancer
lymphedema and fibrosis

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Lymphatic Diseases