Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04606511
Other study ID # S-20200094
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 5, 2020
Est. completion date October 2021

Study information

Verified date February 2021
Source Odense University Hospital
Contact Mads G Jørgensen, MD
Phone 29210114
Email Mads.Gustaf.Jorgensen@rsyd.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date October 2021
Est. primary completion date October 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Circumference tape measurements
centimeter and volume criterias
Indocyanine green lymphangiography
Presence of dermal backflow
bioimpedance spectroscopy
7.5 and 10 L-DEX criterias
Symptom score
using lymph-icf, DASH and SF-36 questionnaires

Locations

Country Name City State
Denmark Department of Plastic and Reconstructive Surgery Odense

Sponsors (1)

Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary sensitivity, specificy, NPV and PPV diagnosotic statistics of lymphedema measurements through study completion, approximately 1 year
See also
  Status Clinical Trial Phase
Completed NCT05507346 - A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema N/A
Completed NCT06067880 - Surgical Intervention and Lymphatic Diseases.
Active, not recruiting NCT04797390 - A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema N/A
Completed NCT02676752 - Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis
Completed NCT06323200 - Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA
Completed NCT02506530 - Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema N/A
Terminated NCT02020837 - A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema Early Phase 1
Completed NCT02253186 - Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema N/A
Recruiting NCT01318785 - Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications Phase 2
Enrolling by invitation NCT02375165 - Biomarkers for the Detection of Lymphatic Insufficiency
Completed NCT01112189 - Use of Stem Cells in Lymphedema Post Mastectomy Phase 1/Phase 2
Completed NCT02308488 - Study of Prone Accelerated Breast And Nodal IMRT N/A
Completed NCT00852930 - Low Level Laser Treatment and Breast Cancer Related Lymphedema Phase 4
Completed NCT00743314 - Single-Photon Emission Computed Tomography, Computed Tomography Lymphoscintigraphy, and Intensity-Modulated Radiation Therapy in Treating Patients Who Have Undergone Surgery for Stage I or Stage II Breast Cancer Early Phase 1
Recruiting NCT06237907 - Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema
Terminated NCT01580800 - National Breast Cancer and Lymphedema Registry
Suspended NCT05366699 - LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy N/A
Completed NCT06249360 - Lymphatic System Reflux After Lymphatic Operation
Completed NCT06220903 - The Effect of Complex Decongestive Therapy in Patients With Lymphedema N/A
Terminated NCT02923037 - Hatha Yoga in Breast Cancer Survivors N/A