Clinical trial · Interventional
Lymphedema Prevention After Lymph Node Emptying
Effectiveness of Lymphedema Prevention Programs After Lymph Node Emptying in Breast Cancer: A Randomized Clinical Trial
NCT04785599CI-TRIAL-00050522completedN/AClinicalTrials.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)
ABSTRACT Object: The impact of morbidity and the deterioration in health-related quality of life for patients with lymphedema after axillary lymph node dissection for breast cancer justify the implementation of prevention programs to decrease the incidence of this chronic condition. The aim was to compare the effectiveness of an experimental prevention program with that of our conventional prevention program. Methods: Clinical randomized trial in two parallel groups over a two-year period. Key words: lymphedema, breast cancer, prevention, rehabilitation
Conditions
Conditions (4)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymphedema | — | UNRESOLVED | — |
| Prevention | — | UNRESOLVED | — |
| Rehabilitation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Compression garment | Device | — | UNRESOLVED |
| Exercices | Behavioral | — | UNRESOLVED |
| Informative talk | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group EC1: Exercices, informative talk
- description
- Group EC1 carried out the conventional prevention program consisting of an informative talk and an exercise program
- interventionNames
- Behavioral: Exercices
- Behavioral: Informative talk
- type
- EXPERIMENTAL
- label
- Group ECCP2: Exercices, informative talk, compression garment
- description
- Group ECCP2 carried out the same program but with the addition of a prophylactic compression garment
- interventionNames
- Behavioral: Exercices
- Behavioral: Informative talk
- Device: Compression garment
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Having undergone a lymph node dissection as part of treatment for primary breast neoplasm * Acceptance of the study conditions and signing of the informed consent Exclusion Criteria: * Tumour recurrences * Metastatic cancer * Open wounds or loss of skin integrity * Dependency or deterioration of higher functions * Arterial insufficiency and deep vein thrombosis * Acute heart failure * Severe peripheral neuropathy * Lymphedema
References
Publications (19)
- BACKGROUNDBaumann FT, Reike A, Hallek M, Wiskemann J, Reimer V. Does Exercise Have a Preventive Effect on Secondary Lymphedema in Breast Cancer Patients Following Local Treatment? - A Systematic Review. Breast Care (Basel). 2018 Oct;13(5):380-385. doi: 10.1159/000487428. Epub 2018 May 3. PMID 30498426
- BACKGROUNDBoccardo FM, Ansaldi F, Bellini C, Accogli S, Taddei G, Murdaca G, Campisi CC, Villa G, Icardi G, Durando P, Puppo F, Campisi C. Prospective evaluation of a prevention protocol for lymphedema following surgery for breast cancer. Lymphology. 2009 Mar;42(1):1-9. PMID 19499762
- BACKGROUNDCavanaugh KM. Effects of early exercise on the development of lymphedema in patients with breast cancer treated with axillary lymph node dissection. J Oncol Pract. 2011 Mar;7(2):89-93. doi: 10.1200/JOP.2010.000136. PMID 21731515
- BACKGROUNDCastro-Sanchez AM, Moreno-Lorenzo C, Mataran-Penarrocha GA, Aguilar-Ferrandiz ME, Almagro-Cespedes I, Anaya-Ojeda J. [Preventing lymphoedema after breast cancer surgery by elastic restraint orthotic and manual lymphatic drainage: a randomized clinical trial]. Med Clin (Barc). 2011 Jul 23;137(5):204-7. doi: 10.1016/j.medcli.2010.09.020. Epub 2010 Dec 8. Spanish. PMID 21145085
- BACKGROUNDCheema BS, Kilbreath SL, Fahey PP, Delaney GP, Atlantis E. Safety and efficacy of progressive resistance training in breast cancer: a systematic review and meta-analysis. Breast Cancer Res Treat. 2014 Nov;148(2):249-68. doi: 10.1007/s10549-014-3162-9. Epub 2014 Oct 17. PMID 25324019
- BACKGROUNDDe Miguel, C., Alonso, B., Hernandez, M., Crespo, M.P., Gil, M.S., 2010. Treatment with compression garments. Rehabilitation, 44 (51), 58-62.
- BACKGROUNDDiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. 2013 May;14(6):500-15. doi: 10.1016/S1470-2045(13)70076-7. Epub 2013 Mar 27.