About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Compressive garments class II
Treatment groups
Sponsors and collaborators
University Hospital, Ghent
Lead sponsor
University Hospital, Louvain
Collaborator
Kom Op Tegen Kanker
Collaborator