Lymphedema Screening

NCT ID: NCT04606511

Last Updated: 2021-02-24

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-05

Study Completion Date

2021-10-31

Brief Summary

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Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, there is no established screening program for lymphedema. This cross-sectional study will investigate diagnostic modalities in screening for lymphedema in patients with and without known lymphedema after breast cancer.

Detailed Description

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Conditions

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Lymphedema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Breast cancer patients with lymphedema

Group Type OTHER

Circumference tape measurements

Intervention Type DIAGNOSTIC_TEST

centimeter and volume criterias

Indocyanine green lymphangiography

Intervention Type DIAGNOSTIC_TEST

Presence of dermal backflow

bioimpedance spectroscopy

Intervention Type DIAGNOSTIC_TEST

7.5 and 10 L-DEX criterias

Symptom score

Intervention Type DIAGNOSTIC_TEST

using lymph-icf, DASH and SF-36 questionnaires

Breast cancer patients without lymphedema

Group Type OTHER

Circumference tape measurements

Intervention Type DIAGNOSTIC_TEST

centimeter and volume criterias

Indocyanine green lymphangiography

Intervention Type DIAGNOSTIC_TEST

Presence of dermal backflow

bioimpedance spectroscopy

Intervention Type DIAGNOSTIC_TEST

7.5 and 10 L-DEX criterias

Symptom score

Intervention Type DIAGNOSTIC_TEST

using lymph-icf, DASH and SF-36 questionnaires

Interventions

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Circumference tape measurements

centimeter and volume criterias

Intervention Type DIAGNOSTIC_TEST

Indocyanine green lymphangiography

Presence of dermal backflow

Intervention Type DIAGNOSTIC_TEST

bioimpedance spectroscopy

7.5 and 10 L-DEX criterias

Intervention Type DIAGNOSTIC_TEST

Symptom score

using lymph-icf, DASH and SF-36 questionnaires

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Previous breast cancer treated with axillary lymph node dissection
* No recurrence
* Understand the study
* Can talk, read and understand Danish

Exclusion Criteria

* Pregnant or breast feeding
* Lymph node dissection from other basins
* Psychiatric disorder
* Not possible to perform indocyanine green lymphangiography
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mads Gustaf Jørgensen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Plastic and Reconstructive Surgery

Odense, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Mads G Jørgensen, MD

Role: CONTACT

29210114 ext. +45

Facility Contacts

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Mads G Jørgensen, MD

Role: primary

Jens A Sørensen, MD, PhD

Role: backup

Other Identifiers

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S-20200094

Identifier Type: -

Identifier Source: org_study_id

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