Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Medical Examination | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Shear Wave Elastography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Skin/soft tissue elasticity assessment
- description
- 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.
- interventionNames
- Procedure: Medical Examination
- Other: Questionnaire Administration
- Procedure: Shear Wave Elastography
Primary outcomes (1)
- measure
- Elasticity values
- timeFrame
- Within 2 weeks of initial study visit
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available