Lymphedema After Gyneco-oncologic Treatment

Recruiting now · Not applicable

Conditions studied: Lymphedema, Genital Neoplasm

In brief

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 towards advanced stage LLL will be evaluated.

Key facts

Study ID

NCT05469945

Run by

University Hospital, Ghent

People needed

218

Starts

2022-06-22

Expected to finish

2028-06-30

Last updated by the study team

2024-06-20

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Ghent University Hospital, Dept. Radiotherapy-Oncology — Ghent, Belgium (enrolling)
• University Hospital, Louvain — Leuven, Belgium (enrolling)

Full record on ClinicalTrials.gov

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