Reduction of Lymphedema Secondary to Breast Cancer (NCT04974268) | Clinical Trial Compass
CompletedNot Applicable
Reduction of Lymphedema Secondary to Breast Cancer
Spain100 participantsStarted 2021-05-17
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the change in volume in the limb affected by lymphedema in the intervention group vs control.
Timeframe: Baseline, 3rd and 6th month visits
Trial details
NCT IDNCT04974268
SponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud