Clinical trial · Interventional
Effectiveness of Fluoroscopy-guided MLD for Treatment of BCRL
Effectiveness of Fluoroscopy-guided Manual Lymph Drainage (MLD) Versus Traditional MLD or Placebo MLD, as Part of Decongestive Lymphatic Therapy, for the Treatment of Breast Cancer-related Lymphoedema (BCRL): a Randomised Controlled Trial
NCT02609724CI-TRIAL-00057192EFforT-BCRLcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Compression therapy | Other | — | UNRESOLVED |
| Fluoroscopy-guided MLD | Other | — | UNRESOLVED |
| Information | Other | — | UNRESOLVED |
| Placebo MLD | Other | — | UNRESOLVED |
| Skin care | Other | — | UNRESOLVED |
| Traditional MLD | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Fluoroscopy-guided MLD
- description
- Information, skin care, compression therapy, exercises and fluoroscopy-guided MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up
- interventionNames
- Other: Information
- Other: Skin care
- Other: Compression therapy
- Other: Fluoroscopy-guided MLD
- type
- ACTIVE_COMPARATOR
- label
- Traditional MLD
- description
- Information, skin care, compression therapy, exercises and traditional MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up
- interventionNames
- Other: Information
- Other: Skin care
- Other: Compression therapy
- Other: Traditional MLD
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (19)
- BACKGROUNDHuang TW, Tseng SH, Lin CC, Bai CH, Chen CS, Hung CS, Wu CH, Tam KW. Effects of manual lymphatic drainage on breast cancer-related lymphedema: a systematic review and meta-analysis of randomized controlled trials. World J Surg Oncol. 2013 Jan 24;11:15. doi: 10.1186/1477-7819-11-15. PMID 23347817
- BACKGROUNDEzzo J, Manheimer E, McNeely ML, Howell DM, Weiss R, Johansson KI, Bao T, Bily L, Tuppo CM, Williams AF, Karadibak D. Manual lymphatic drainage for lymphedema following breast cancer treatment. Cochrane Database Syst Rev. 2015 May 21;2015(5):CD003475. doi: 10.1002/14651858.CD003475.pub2. PMID 25994425
- BACKGROUNDDevoogdt N, Christiaens MR, Geraerts I, Truijen S, Smeets A, Leunen K, Neven P, Van Kampen M. Effect of manual lymph drainage in addition to guidelines and exercise therapy on arm lymphoedema related to breast cancer: randomised controlled trial. BMJ. 2011 Sep 1;343:d5326. doi: 10.1136/bmj.d5326. PMID 21885537
- BACKGROUNDDevoogdt N, Van Kampen M, Geraerts I, Coremans T, Christiaens MR. Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF): reliability and validity. Phys Ther. 2011 Jun;91(6):944-57. doi: 10.2522/ptj.20100087. Epub 2011 Apr 14. PMID 21493748
- BACKGROUNDDevoogdt N, Lemkens H, Geraerts I, Van Nuland I, Flour M, Coremans T, Christiaens MR, Van Kampen M. A new device to measure upper limb circumferences: validity and reliability. Int Angiol. 2010 Oct;29(5):401-7. PMID 20924341
- BACKGROUNDDevoogdt N, Pans S, De Groef A, Geraerts I, Christiaens MR, Neven P, Vergote I, Van Kampen M. Postoperative evolution of thickness and echogenicity of cutis and subcutis of patients with and without breast cancer-related lymphedema. Lymphat Res Biol. 2014 Mar;12(1):23-31. doi: 10.1089/lrb.2013.0028. Epub 2014 Feb 6. PMID 24502300
- BACKGROUNDGebruers N, Truijen S, Engelborghs S, De Deyn PP. Volumetric evaluation of upper extremities in 250 healthy persons. Clin Physiol Funct Imaging. 2007 Jan;27(1):17-22. doi: 10.1111/j.1475-097X.2007.00708.x.