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

NCT ID: NCT04457375

Last Updated: 2021-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-16

Study Completion Date

2021-01-15

Brief Summary

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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

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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.

Conditions

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Lymphedema, Secondary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Adults

Healthy

TDC

Intervention Type DIAGNOSTIC_TEST

measurements

Interventions

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TDC

measurements

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nova Southeastern University

OTHER

Sponsor Role lead

Responsible Party

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Harvey Mayrovitz

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nova Southeastern University

Fort Lauderdale, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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2019-595-NSU

Identifier Type: -

Identifier Source: org_study_id

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