Which factors, diagnostic tools and treatment options can have aninfluence on the development of lymphedema after breast cancer?

Phase 1

Conditions: breast cancer patientslymphedema
MedDRA version: 20.0Level: LLTClassification code 10025233Term: LymphedemaSystem Organ Class: 100000013375
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2017-002306-12-BE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 125

Inclusion Criteria

- Age >18y (since the investigation using ICG is not dangerous for
pregnant women, women with child bearing age are included)
- Women/ men with breast cancer and scheduled for unilateral axillary
lymph node dissection (ALND) or sentinel node biopsy (SNB)
- Oral and written approval of informed consent
- Understands Dutch
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

- Age <18y
- Oedema of the upper limb from other causes
- Cannot participate during the entire study period
- Mentally or physically unable to participate in the study
- Contra-indication for the use of ICG: allergy to iodine,
hyperthyroidism
- Metastatic disease

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective entails detecting early development of lymphedema<br>and establishing a decrease in the incidence of lymphedema and/or<br>improvement or stabilization of the lymphofluoroscopic image when<br>treatment is started early.;Secondary Objective: Establishing pre-existing factors in the development of lymphedema<br>after breast cancer treatment.;Primary end point(s): - Incidence of lymphoedema of arm and hand (defined as 5% volume<br>increase compared to the contralateral side)<br>- Change of lymphatic architecture and function;Timepoint(s) of evaluation of this end point: at 36 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Change of extracellular fluid in the arm<br>- Change of water content of the arm<br>- Change of quality of life<br>- Number of episodes of erysipelas<br>- Number of adverse events to the garment;Timepoint(s) of evaluation of this end point: at 36 months