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

Lymphedema, Secondary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04457375
• Other study ID #: 2019-595-NSU
• Status: Completed
• Start date: January 16, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: June 2021
• Source: Nova Southeastern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Known to have diabetes of any type.

2. Having facial or neck hair that prohibits accurate measurements

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Lymphedema
• Lymphedema, Secondary

Intervention

Diagnostic Test:
• TDC
measurements

Locations

Country	Name	City	State
United States	Nova Southeastern University	Fort Lauderdale	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nova Southeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck-to-Arm TDC ratio	Neck-to-Arm TDC ratio	one year
Primary	Sub-Mental-to-Arm TDC ratio	Sub-Mental-to-Arm TDC ratio	one year
Secondary	Bilateral values and Variability in TDC values	Bilateral values and Variability in TDC values	one year