Clinical trial · Interventional
Physiotherapy Program Impact on Breast Cancer-Related Lymphedema
Effect of a Physiotherapy Program Based on Concurrent Strength and Moderate-to-high Intensity Aerobic Exercise Training, Along With Cohesive Bandaging, in Women With Breast Cancer-related Lymphedema.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was discontinued because the estimated sample size necessary to obtain adequate statistical power was not reached.
Summary
Brief summary (as posted)
Breast Cancer Related Lymphedema (BCRL) is a sequela resulting from the application of certain treatments, such as axillary lymph node dissection and regional lymph node radiation. The main objective of the present clinical trial is to determine the effectiveness of moderate-high intensity strength training in combination with an aerobic exercise protocol and the application of cohesive compression bandaging in subjects with or at risk for BCRL and to analyze the acute responses of the molecular, functional and clinical profile of patients with BCRL or at risk after two sessions of intervention. To compare proteomic analysis of patients or at risk with healthy controls and to assess the adaptations produced after 12 weeks of exercise intervention and over a 12-week post-intervention period in patients with BCRL or at risk.
Conditions
Conditions (1)
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 Related Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 12-week supervised exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lymphedema experimental
- description
- Subjects belonging to this group perform a 12-week supervised exercise. The patients will follow a moderate-to-high intensity strength exercise protocol, along with the application of a cohesive bandage (bandage will only be applied in subjects with Breast Cancer-Related Lymphedema, BCRL, and not in patients at risk).
- interventionNames
- Other: 12-week supervised exercise
- type
- NO_INTERVENTION
- label
- Healthy control
- description
- Subjects belonging to this group perform a 1-week supervised exercise, following the same training protocol as experimental group (arm 1). This group will not receive cohesive compressive bandage.
Primary outcomes (29)
- measure
- Molecular variables: proteome.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer survivors who have completed treatment (chemotherapy, surgery, and/or radiotherapy) at least 6 months prior to randomization for the trial. * Patients diagnosed with unilateral stage I or II BCRL as established by the International Society of Lymphology Congress Working Group in 2020, or patients at risk of developing unilateral BCRL (who have received radiotherapy in the axillary region/radical mastectomy/modified radical mastectomy and lymph node dissection/breast surgery and sentinel lymph node biopsy). * Age between 18 and 65 years. * Voluntary participation in the study and informed consent. Exclusion Criteria: * Recent surgery (\<3 months) or planned surgery during the study period. * Patients with cognitive impairment. * Patients with bilateral lymphedema. * Health problems or illnesses that prevent them from participating in the intervention. * Other serious conditions that may affect their HRQOL (Health-Related Quality of Life).
References
Publications (1)
- BACKGROUNDExecutive Committee of the International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2020 Consensus Document of the International Society of Lymphology. Lymphology. 2020;53(1):3-19. PMID 32521126