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Lymphedema After Gyneco-oncologic Treatment

RecruitingNAAges 18 Years - 99 YearsFemaleUniversity Hospital, Ghent
NCT05469945 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Trial developed to inventory the incidence of early and advanced stage lower limb lymphedema in patients diagnosed with and treated for gynaecologic cancer. Four hundred patients with diagnosis stage 1-3 gynaecologic cancer will be included in an observational cohort between diagnosis until maximum 2 weeks after start of the first treatment. They will be followed for occurrence of lower limb lymphedema up till 2 years after their last treatment. Data on signs and symptoms, quality of life, time investment and financial expenses will be collected, to provide information on the incidence and risk factors for lower limb lymphedema, and on its impact on patients, regarding quality of life, sexual well-being and time- and financial investment. Patients developing early stage LLL enter an interventional sub-cohort, in which the effect of class II compressive garments on preventing evolution

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📋 Eligibility rules (as published)
Inclusion Criteria: * Signed informed consent (ICF) * Female patient, recently diagnosed with gynaecologic cancer (cervix, endometrium, vulva, vagina, ovaries…) and candidate for curative treatment * Age ≥ 18 years * Understanding of the Dutch language * Able to understand the informed consent and willing to comply with the protocol, including use of diary or app and timely completion of requested questionnaires. Exclusion Criteria: * History of treatment for gynaecologic cancer * Concurrent second primary tumor(s) * Pregnancy or pregnancy planned within 2 years * Known metastasized cancer at the time of inclusion (D0) * Severe injury, surgery or deformation of the legs or groins in the past * Vascular malformation of the leg or untreated venous insufficiency with oedema (CEAP C4 or more) * Mental or psychological problems, inability to comply to the study protocol * First treatment administered \> 2 weeks before * Clinical signs and symptoms of lymphedema present (ISL stage 0 or higher) at the moment of intake
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What it tests

  • Compressive garments class II
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Where

2 sites
Ghent University Hospital, Dept. Radiotherapy-Oncology
Ghent, Belgium
University Hospital, Louvain
Leuven, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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