RecruitingNCT07011316

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

Subclinical Assessment and Monitoring of Lymphatic System Function in Oncology Patients as Part of Physiotherapeutic Prevention of Limb Lymphoedema


Sponsor

The Greater Poland Cancer Centre

Enrollment

600 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria12

  • 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.

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Locations(1)

The Greater Poland Cancer Centre

Poznan, Greater Poland Voivodeship, Poland

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NCT07011316


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