Clinical Trials /

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

NCT02676752

Description:

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.

Related Conditions:
  • Head and Neck Carcinoma
Recruiting Status:

Active, not recruiting

URL:

https://clinicaltrials.gov/show/NCT02676752

Trial Eligibility

Document

Title

  • Brief Title: Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis
  • Official Title: Assessing Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors

Clinical Trial IDs

  • ORG STUDY ID: VICC HN 15135
  • SECONDARY ID: NCI-2016-00069
  • SECONDARY ID: VICC HN 15135
  • SECONDARY ID: P30CA068485
  • NCT ID: NCT02676752

Conditions

  • Lymphedema

Purpose

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.

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.

Trial Arms

NameTypeDescriptionInterventions
Skin/soft tissue elasticity assessmentParticipants 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.

    Eligibility 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
    Maximum Eligible Age:N/A
    Minimum Eligible Age:22 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Elasticity values
    Time Frame:Within 2 weeks of initial study visit
    Safety Issue:
    Description: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

    Measure:Strength of associations of tissue elasticity and current conventional methods
    Time Frame:Within 2 weeks of initial study visit
    Safety Issue:
    Description: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.

    Details

    Phase:
    Primary Purpose:Observational
    Overall Status:Active, not recruiting
    Lead Sponsor:Vanderbilt-Ingram Cancer Center

    Trial Keywords

    • head and neck cancer
    • lymphedema and fibrosis

    Last Updated

    May 8, 2020