Skin Biophysical Measures for Assessing Head and Neck Cancer-Related External Lymphedema

Completed

• Conditions: Lymphedema, Secondary
• Interventions: Diagnostic Test: TDC

• Registration Number: NCT04457375
• Lead Sponsor: Nova Southeastern University

Brief Summary

Selected measurements in healthy persons of skin tissue dielectric constant as reference values for subsequent use to evaluate patients with head and neck lymphedema.

Detailed Description

Skin tissue dielectric constant (TDC) measurements will non-invasively be made bilaterally at two neck sites, bilaterally on two forearm sites and one site at the chin sub-mental area.

Measurements are made with subjects fully clothed and seated. Measurements are made in triplicate and averaged at each site. Full measurements take about 5-7 minutest to complete. Data will be analyzed to determine the neck-to-arm ratios and chin-to-arm ratios to establish normal ranges of these parameters for subsequent use as comparisons to evaluate and track changes in patients with head and neck lymphedema.

Study Timeline

• Study Start: 2020-01-16
• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-07
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-15
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-07
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Healthy with no current or past skin conditions affecting neck or arms

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Exclusion Criteria

1. Known to have diabetes of any type.
2. Having facial or neck hair that prohibits accurate measurements

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Adults	TDC	Healthy

Primary Outcome Measures

Name	Time	Method
Sub-Mental-to-Arm TDC ratio	one year	Sub-Mental-to-Arm TDC ratio
Neck-to-Arm TDC ratio	one year	Neck-to-Arm TDC ratio

Secondary Outcome Measures

Name	Time	Method
Bilateral values and Variability in TDC values	one year	Bilateral values and Variability in TDC values

Trial Locations

Locations (1)

Nova Southeastern University; 🇺🇸 Fort Lauderdale, Florida, United States