Clinical trial NCT07011316: Subclinical Monitoring of Lymphatic Function in Oncology Patients for Lymphoedema Prevention (ONCOLYMPH)
Official title: Subclinical Assessment and Monitoring of Lymphatic System Function in Oncology Patients as Part of Physiotherapeutic Prevention of Limb Lymphoedema
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoedema
Keywords: Lymphoedema
Cancer
Prevention
bioimpedance spectroscopy
Lead sponsor: The Greater Poland Cancer Centre
Sponsor class: OTHER
Collaborators: name: Poznan University of Physical Education
First posted: 2025-06-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: Lymphoedema is a chronic condition characterised by an increase in body volume due to the accumulation of protein-rich fluid and cellular debris in the interstitial spaces, resulting from impaired lymphatic vessel function. It can affect various areas of the body, such as the external genitalia, abdomen, and face, but most commonly occurs in the limbs, leading to visible swelling and associated discomfort.

The main risk factors for lymphoedema include lymphadenectomy, radiotherapy, extensive surgical procedures, and obesity. Oncology patients frequently experience this condition as a complication of cancer treatment. According to data from the World Health Organization, up to 30% of breast cancer survivors develop lymphoedema. It is also a common complication in patients treated for other cancers usually as a result of surgical removal of lymph nodes or radiotherapy that damages structures of the lymphatic system (cancer of the: cervix \~ 30%; vulva \~ 27%; sarcoma \~ 27%; penis \~ 25% melanoma \~ 23%; prostate \~ 18%; bladder \~ 15%; testes: \~ 10%).

Lymphoedema diagnosis is based on clinical examination and the exclusion of other causes, primarily chronic venous insufficiency and thrombosis. Standard diagnostic methods like lymphoscintigraphy and indocyanine green (ICG) dye lymphography require specialised equipment and conditions, making them less suitable for routine screening to assess lymphatic damage and the risk of lymphoedema development.

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. According to the International Society of Lymphology (ISL), lymphoedema treatment should be interdisciplinary, incorporating a comprehensive range of therapeutic approaches such as pharmacotherapy, surgery, multi-layer compression, pneumatic compression, manual lymphatic drainage, and specialised exercises to enhance lymph flow. As the course of treatment is prolonged and the results are not fully satisfactory, methods and programmes to prevent the formation and development of lymphoedema are of particular importance, both clinically and economically.

Regular monitoring of lymphatic system function in oncology patients and the early implementation of physiotherapy can significantly reduce the risk of lymphoedema or limit its severity, ultimately improving patients' quality of life and recovery outcomes.

Purpose of the research: The aim of the project is to assess early - subclinical peripheral lymphatic system dysfunction resulting from various treatment modalities (surgery, radiotherapy, brachytherapy) in oncology patients. The study will include patients with breast cancer, malignant urinary and genital cancers, both treated surgically and/or with brachytherapy. Recruited patients' body composition will be assessed using non-invasive technology of spectroscopic bioimpedance analysis (BIA) with a body composition analyser - SOZO® Digital Health Platform apparatus. Measurements will be taken three times: (1) before the start of treatment on admission to the hospital, (2) after the applied treatment before the patient is discharged, and (3) at the standard follow-up visit two/three months after the end of treatment in the hospital. The assessment of the efficiency of the lymphatic system provides information on the appropriateness of taking preventive measures to prevent the development of lymphoedema of the limbs.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* age ≤ 18 years,
* cardiac arrhythmia,
* pacemakers or other implanted electronic devices,
* history of external defibrillation,
* pregnancy,
* critical limb ischaemia,
* advanced heart failure (NYHA III and IV0),
* symptoms of deep vein thrombosis,
* uncompensated heart, kidney or thyroid failure,
* peripheral nerve damage,
* presence of psychiatric disorders that preclude informed consent or limit appropriate co-operation of the patient,
* lack of informed consent from the patient to participate in the study.

Primary outcomes:
measure: L-Dex ratio
timeFrame: 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:
measure: BMI
timeFrame: 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)
measure: Percent body fat
timeFrame: 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)
measure: Percent body water
timeFrame: 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:
Locations:
city: Poznań
country: Poland
facility: The Greater Poland Cancer Centre
state: Greater Poland
Study officials:
affiliation: The Greater Poland Cancer Centre
name: Janusz Doś, PT, PhD
role: PRINCIPAL_INVESTIGATOR
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