NCT02676752

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

2.6 years

First QC Date

February 3, 2016

Last Update Submit

February 7, 2022

Conditions

Lymphedema

Keywords

head and neck cancerlymphedema and fibrosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Strength of associations of tissue elasticity and current conventional methods

    Within 2 weeks of initial study visit

Study Arms (1)

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 ExaminationOther: Questionnaire AdministrationProcedure: Shear Wave Elastography

Interventions

Medical ExaminationPROCEDURE

Evaluation of secondary lymphedema and fibrosis (LEF) status

Also known as: Exam, Examination, Medical Assessment, Medical Exam, Medical Inspection
Skin/soft tissue elasticity assessment
Questionnaire AdministrationOTHER

Completion of questionnaires

Skin/soft tissue elasticity assessment
Shear Wave ElastographyPROCEDURE

Undergo ultrasound shear wave elastrography

Also known as: Transient Elastography
Skin/soft tissue elasticity assessment

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults 22 years and older that are head and neck cancer survivors and have lymphedema and fibrosis.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Links

MeSH Terms

Conditions

LymphedemaHead and Neck NeoplasmsFibrosis

Interventions

Independent Medical EvaluationRestraint, Physical

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationBehavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Kenneth Niermann

    Vanderbilt University/Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 8, 2016

Study Start

September 1, 2016

Primary Completion

April 1, 2019

Study Completion

August 1, 2021

Last Updated

February 9, 2022

Record last verified: 2022-02

Locations

US(1)