Subclinical Monitoring of Lymphatic Function in Oncology Patients for Lymphoedema Prevention (ONCOLYMPH)

ConditionLymphoedema
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Greater Poland Cancer Centre

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 1 trial group
Group A: Main patient cohort

Trial outcomes

Primary outcomes

1

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.

Time frame
Time Frame: Metrics assessed at baseline (within two weeks before treatment), after treatment (up to 2 weeks after completing treatment/intervention), and during follow-up (up to 8 weeks ± 2 weeks after completing treatment/intervention)

Secondary outcomes

1

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.

Time frame
Time Frame: Metrics assessed at baseline (within two weeks before treatment), after treatment (up to 2 weeks after completing treatment/intervention), and during follow-up (up to 8 weeks ± 2 weeks after completing treatment/intervention)
2

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.

Time frame
Time Frame: Metrics assessed at baseline (within two weeks before treatment), after treatment (up to 2 weeks after completing treatment/intervention), and during follow-up (up to 8 weeks ± 2 weeks after completing treatment/intervention)
3

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.

Time frame
Time Frame: Metrics assessed at baseline (within two weeks before treatment), after treatment (up to 2 weeks after completing treatment/intervention), and during follow-up (up to 8 weeks ± 2 weeks after completing treatment/intervention)

Other outcomes

Sponsors and contacts

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The Greater Poland Cancer Centre

Lead sponsor

Poznan University of Physical Education

Collaborator