About this trial
Lymphoedema, a chronic condition caused by the accumulation of protein-rich fluid in the intercellular spaces due to impaired lymphatic function, is a common complication in cancer patients. It can lead to visible swelling, discomfort, and mobility issues, but most frequently affects the limbs. This condition not only impacts patients physically but also has significant psychological consequences, including reduced quality of life, social stigma, and challenges with returning to daily activities.
Oncology patients are particularly at risk for developing lymphoedema due to factors such as lymphadenectomy, radiotherapy, and extensive surgical procedures. Up to 30% of breast cancer survivors develop lymphoedema, and it is also a common complication in patients treated for other cancers, such as those involving the cervix, vulva, prostate, and bladder. Despite the importance of early detection, diagnostic tools for assessing lymphatic dysfunction are often specialised and not suitable for routine screening in clinical practice.
The primary goal of this study is to explore the early signs of lymphatic dysfunction in cancer patients before evident clinical symptoms, with the aim of identifying individuals at risk of developing lymphoedema. This will provide valuable information that could guide early interventions and preventive measures to reduce the severity or even prevent the onset of lymphoedema. By focusing on early, subclinical dysfunction, the study seeks to contribute to improving both the clinical management of lymphatic complications and the overall quality of life for oncology patients. Regular monitoring and timely physiotherapy interventions could play a key role in enhancing recovery outcomes and reducing the long-term impact of lymphoedema.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
admission to the Greater Poland Cancer Centre for treatment in one of the departments participating in the study,
age ≥ 18 years,
ability to balance independently in a standing position for 30 seconds,
obtaining the patient's written informed consent to participate in the study.
Disqualifiers
age ≤ 18 years,
cardiac arrhythmia,
pacemakers or other implanted electronic devices,
history of external defibrillation,
Trial population
Individuals affected by lymphoedema experience not only physical symptoms such as inflammation and mobility issues but also psychological effects, including reduced quality of life, social stigma, and challenges in returning to work.
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
L-Dex ratio
The assessment of lymphoedema will be performed using non-invasive technology of spectroscopic bioimpedance analysis (BIA) with a body composition analyser - SOZO® Digital Health Platform apparatus and measured as L-Dex parameter. L-Dex ratio will be calculated by dividing the bioimpedance reading of the affected limb by the bioimpedance reading of the unaffected limb.
Secondary outcomes
BMI
Body Mass Index; weight in kilograms (kg) and height in meter (m) will be combined to report BMI in kg/m\^2. The parameters will be measured using spectroscopic bioimpedance analysis (BIA) with a body composition analyser - SOZO® Digital Health Platform apparatus.
Percent body fat
Body fat mass in kilograms (kg) and weight in kilograms (kg) will be combined to report Percent body fat in kg/kg\*100 (%). The parameters will be measured using spectroscopic bioimpedance analysis (BIA) with a body composition analyser - SOZO® Digital Health Platform apparatus.
Percent body water
Total body water mass in kilograms (kg) and weight in kilograms (kg) will be combined to report Percent total body water in kg/kg\*100 (%). The parameters will be measured using spectroscopic bioimpedance analysis (BIA) with a body composition analyser - SOZO® Digital Health Platform apparatus.
Sponsors and contacts
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The Greater Poland Cancer Centre
Lead sponsor
Poznan University of Physical Education
Collaborator