N/A
Completed N=194
Effectiveness of Fluoroscopy-guided MLD for Treatment of BCRL
Breast Neoplasm · Lymphedema
Source: ClinicalTrials.gov NCT02609724 ↗
Enrolled (actual)
194
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Lymphoedema Volume at the Level of the Arm/ Hand — 1.228; 1.249; 1.218; 1.175 Inter-limb ratio
Summary
The main scientific objective of this multicentric double-blinded randomised controlled trial entails examining the effectiveness of fluoroscopy-guided MLD versus traditional MLD versus placebo MLD, applied as part of the intensive and maintenance phase of Decongestive Lymphatic Therapy, for the treatment of BCRL Secondary scientific objectives entail examining the relationship between different variables of lymphoedema at baseline
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lymphoedema Volume at the Level of the Arm/ Hand |
1.228; 1.249; 1.218; 1.175; 1.197; 1.164 | — |
| PRIMARY Stagnation of Fluid at Level of the Shoulder/ Trunk |
1.045; 1.051; 1.057; 1.088; 1.059; 1.077 | — |
| SECONDARY Extracellular Fluid in the Upper Limb |
33.1; 32.3; 34.9; 24.4; 25.4; 23.9 | — |
| SECONDARY Thickness of Cutis and Subcutis of Arm and Trunk Measured With Ultrasound |
1.52; 1.44; 1.45; 1.36; 1.38; 1.36 | — |
| SECONDARY Problems in Functioning Related to Development of Breast Cancer-related Lymphoedema |
38.0; 35.7; 38.1; 29.0; 27.7; 32.1 | — |
| SECONDARY Elasticity of Skin and Subcutaneous Tissue of Arm and Trunk Using the SkinFibrometer |
1.28; 1.26; 1.41; 1.11; 1.06; 1.14 | — |
| SECONDARY Quality of Life Score |
5.96; 6.15; 5.87; 6.06; 6.18; 5.82 | — |
| SECONDARY Number of Episodes of Erysipelas |
5; 8; 7 | — |
| SECONDARY Overall Treatment Satisfaction |
80; 78; 80 | — |
| SECONDARY Manual Lymphatic Drainage (MLD)-Specific Treatment Satisfaction |
8; 7; 7 | — |
| SECONDARY Local Tissue Water at the Level of the Arm and Trunk |
1.418; 1.354; 1.406; 1.372; 1.292; 1.344 | — |
| SECONDARY Thickness of the Cutis and Subcutis of the Arm and Trunk Evaluated by Palpation (Pinch Test) |
4.43; 4.03; 4.65; 4.62; 4.23; 4.57 | — |
| SECONDARY Hardness (Fibrosis) of the Skin at the Level of the Arm and Trunk Evaluated Through Palpation |
0.49; 0.26; 0.24; 0.40; 0.44; 0.56 | — |
| SECONDARY Lymphatic Architecture and Function |
— | — |
Eligibility Criteria
Inclusion Criteria
- Age >18y (since the treatment with MLD and the investigation using ICG is not dangerous for pregnant women, women with child bearing age are included)
- Women/ men with breast cancer-related lymphoedema
- Chronic lymphoedema (>3 months present), stage I to IIb
- At least 5% difference between both arms and/ or hands, adjusted for dominance
- Written informed consent obtained
Exclusion Criteria
- Allergy for iodine, sodiumiodine, ICG
- Increased activity of the thyroid gland; benign tumors of the thyroid gland
- Age <18y
- Oedema of the upper limb from other causes
- Active metastasis of the cancer
- Surgery of the lymphatic system in the past (lymph node transplantation, lymphovenous shunt)
- Cannot participate during the entire study period
- Mentally or physically unable to participate in the study
Data sourced from ClinicalTrials.gov (NCT02609724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.