Clinical trial · Interventional
Reduction of Lymphedema Secondary to Breast Cancer
Reduction of Lymphedema Secondary to Breast Cancer Through a Structured Exercise and Weight Loss Program. Randomized Controlled Trial
NCT04974268CI-TRIAL-00086023EJERDIETLIFcompletedN/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)
This study evaluates the reduction of lymphedema and its complications in obese women treated with a muscle training and weight loss program as well as the improvement body composition, muscle strength, quality of life and neurocognitive function, compared to a conventional treatment control group.
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 |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Specific supervised exercise and weight loss program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise and nutritional program
- description
- Intervention group that receives supervised exercise and weight loss program based on individual and group intervention with Mediterranean diet and substitute for a daily meal (non-mandatory), manual lymphatic drainage and compression garment if there is more than 600 ml of excess volume in the limb affected.
- interventionNames
- Other: Specific supervised exercise and weight loss program
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Control group will receive recommendations for aerobic unsupervised exercise 150 min per week, standard dietary recommendations (Mediterranean diet pattern and 1800 Kcal diet), manual lymphatic drainage and compression garment if there is more than 600 ml of excess volume in the limb affected.
Primary outcomes (1)
- measure
- To assess the change in volume in the limb affected by lymphedema in the intervention group vs control.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients older than 18 years and under 80 who have lymphedema diagnosed according to the truncated cone formula (increase of \> 200 ml with respect to the contralateral) and are referred to Rehabilitation for treatment. * Having completed the chemotherapy and radiotherapy treatment at least 6 months prior to randomization. * Not having received manual lymphatic drainage in the 2 months prior to the intervention. * BMI \> 25 y \< 40 kg/m2. * Signature of informed consent. Exclusion Criteria: * Traumatological, neurological, rheumatological or cardiovascular problems that prevent patients from performing the training. * Phase IIIB structured lymphedema * Metastatic disease. * Illness that prevents the subject from carrying out the program. * Unstable heart disease * Ejection fraction of the left ventricle higher than 35. * Voluntary or involuntary weight loss \> 10% in the last 3 months. * Illiterate. * Those who do not sign the informed consent to participate in the study. * Abusive intake of alcohol or other dependencies that in the opinion of the investigator could interfere with the study.
References
Publications (0)
Data not yet available
No reference posted for this study.