Clinical trial · Interventional
Lymphatic Response to Resistance Exercise in Breast Cancer Survivors
Prevention-Related Lymphatic Response to Resistance Exercise in Breast Cancer Survivors at Risk of Breast Cancer-Related Lymphedema
NCT06113627CI-TRIAL-00071020LinfoGYMnot yet recruitingN/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)
The objective of this study is 1) to study the acute and chronic effect of resistance therapeutic physical exercise (RTPE) in the prevention of breast cancer-related lymphedema (BCRL) in breast cancer survivors at risk using variables related to the lymphatic response; 2) Study the possible relationship between changes in body composition at a local and regional level and volume changes produced by RTPE in patients at risk of suffering from BCRL.
Conditions
Conditions (3)
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 Lymphedema | — | UNRESOLVED | — |
| Lymphedema of Upper Limb | — | UNRESOLVED | — |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Resistance Therapeutic Exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise group
- description
- The intervention group will receive a total of 24 sessions of Therapeutic Resistance Exercise, distributed in 2 weekly sessions of 50 minutes during 3 months.
- interventionNames
- Other: Resistance Therapeutic Exercise
- type
- NO_INTERVENTION
- label
- Control group
- description
- The control group will receive an educational booklet containing generalized mobility exercises such as frontal and lateral shoulder raises and rotations (hands to head, hands behind back). This is usually the usual treatment, since in most centers, patients are only referred for treatment of LACM when it is already established.
Primary outcomes (1)
- measure
- Changes in volume difference between extremities (%)
- timeFrame
- Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women diagnosed with breast cancer * Being of legal age * Histologically confirmed primary Breast Cancer (I-IIIA) (without the presence of metastasis) with a diagnosis in the last year * Unilateral involvement * Surgery for the tumor at least 6 weeks before the start of the intervention * WHO performance status of 0 (asymptomatic, complete and ambulatory activity) * Correct understanding of Spanish * Approval by signing the informed consent; * Mus be considered at risk for developing LACM: 1) Have undergone surgery that includes axillary dissection; 2) Have received or are undergoing regional lymph node radiation; 3) BMI \>30 kg/m2. . These patients are considered to have stage 0, subclinical or latent according to the International Society of Lymphology (ISL) , since they will not present signs or symptoms, but lymphatic transport will be altered by the treatments themselves Exclusion Criteria: * Women already diagnosed with LACM in stage I, II or III according to the ISL or if they present an L-Dex ratio \> 10 or a difference in volume equal to or greater than 10% between both extremities * Suffer from or have been diagnosed with any other lymphatic-venous disease in the upper extremity, such as venous insufficiency, thrombosis or lipedema; * Suffer from conditions that prevent resistance exercise of the upper body * Participation in regular (\>1 time/week) and intense exercises involving the upper extremity during the last month * Suffer from heart disease * Inability to complete questionnaires; * A physical condition that prevents them from making hospital visits * Taking any drug that may affect the lymphatic and circulatory system, such as diuretics or corticosteroids * Women which presents some type of wound or infection on the skin.
References
Publications (7)
- BACKGROUNDRoldán-Jiménez C. What are the physiologic effects of Resistance Exercise behind breast cancer-related lymphedema prevention? Medical Hypotheses Volume 171, February 2023, 111022. https://doi.org/10.1016/j.mehy.2023.111022
- BACKGROUNDRoldan-Jimenez C, Pajares B, Ruiz-Medina S, Trinidad-Fernandez M, Gonzalez-Sanchez M, Ribelles N, Garcia-Almeida JM, Rios-Lopez MJ, Alba E, Cuesta-Vargas AI. Design and implementation of a standard care programme of therapeutic exercise and education for breast cancer survivors. Support Care Cancer. 2022 Feb;30(2):1243-1251. doi: 10.1007/s00520-021-06470-9. Epub 2021 Aug 31. PMID 34463835
- BACKGROUNDGutierrez-Sanchez D, Pajares-Hachero BI, Trinidad-Fernandez M, Escriche-Escuder A, Iglesias-Campos M, Bermejo-Perez MJ, Alba-Conejo E, Roldan-Jimenez C, Cuesta-Vargas A. The Benefits of a Therapeutic Exercise and Educational Intervention Program on Central Sensitization Symptoms and Pain-Related Fear Avoidance in Breast Cancer Survivors. Pain Manag Nurs. 2022 Aug;23(4):467-472. doi: 10.1016/j.pmn.2022.01.003. Epub 2022 Mar 9. PMID 35277360
- BACKGROUNDRoldan-Jimenez C, Martin-Martin J, Pajares B, Ribelles N, Alba E, Cuesta-Vargas AI. Factors associated with upper limb function in breast cancer survivors. PM R. 2023 Feb;15(2):151-156. doi: 10.1002/pmrj.12731. Epub 2021 Nov 23. PMID 34713595
- BACKGROUNDEscriche-Escuder A, Trinidad-Fernandez M, Pajares B, Iglesias-Campos M, Alba E, Cuesta-Vargas AI, Roldan-Jimenez C. Ultrasound use in metastatic breast cancer to measure body composition changes following an exercise intervention. Sci Rep. 2021 Apr 23;11(1):8858. doi: 10.1038/s41598-021-88375-5. PMID 33893370
- BACKGROUNDDavies C, Levenhagen K, Ryans K, Perdomo M, Gilchrist L. Interventions for Breast Cancer-Related Lymphedema: Clinical Practice Guideline From the Academy of Oncologic Physical Therapy of APTA. Phys Ther. 2020 Jul 19;100(7):1163-1179. doi: 10.1093/ptj/pzaa087. PMID 32589208